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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation:
The skin irritation potential of the substance (EC 406-176-9) has been assessed by a study on substance itself and supported by reading across the results of studies conducted on two structurally similar analogue substances. It is proposed that these results can be used in the assessment of the target substance (EC 406-176-9).
Study on target substance (EC 406-176-9):
No dermal irritation was observed in 6 rabbits following a single application of test material for 4 hours.
Source Substance; 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC-413 -110 -2):
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion) and Method B4 of Commission Directive 92/69/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of 3 rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation.
The test material produced a primary irritation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP).
Source Substance; 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5):
The method used was designed to meet the requirements of OECD Guideline No. 404.
Test material, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.
No skin irritation was observed in any animal at any assessment.
Eye Irritation:
The eye irritation potential of the substance (EC 406-176-9) has been assessed by a study on substance itself and supported by reading across the results of studies conducted on two structurally similar analgoue substances. It is proposed that these results can be used in the assessment of the target substance (EC 406-176-9).
Study on target substance (EC 406-176-9):
No adverse effects were observed for the iris or corneal damage at any time point in any animal.
Minor conjuncitval irritation (redness) was observed in 4 animals and minor chemosis was observed in 1 animal. All eyes were normal after 1 day.
A single application of test material into the rabbit eye did not produce a positive response according to CLP criteria.
Source Substance; 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC-413 -110 -2):
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC.
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Treated eyes appeared normal at the 48 or 72-hour observations.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to Regulation (EC) No. 1272/2008 (CLP).
Source Substance; 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5):
The method used was designed to meet the requirements of OECD Guideline No. 405.
Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.
One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.
The slight irritation (redness) was fully reversible and not sufficient for classification.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- used to moisten application site
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Four days
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect at any time point
- Irritant / corrosive response data:
- There was no irritation response in any animals observed throughout the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No dermal irritation was observed in 6 rabbits following a single application of test material for 4 hours.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 September to 2 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.56 to 2.61 kg
- Housing: animals were housed individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 20 °C
- Humidity (%): 58 to 78 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/ 12
- on 2 occasions the relative humidity was above the limit specified in the study protocol (70 %). This deviation was considered not to affect the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test material, moistened with 0.5 mL of distilled water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm cotton gauze patch secured with surgical adhesive tape
- Type of wrap if used: the trunk of each animal was wrapped in an elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scheme - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 2 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 27 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No erythema/eschar observed at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 167 - female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 2 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 27 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 167 - female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritant / corrosive response data:
- The individual scores for erythemaleschar and oedema, are given in Table 1 (see attached background material)
Mean values required for EU labelling regulations are given in Table 2 (see attached background material).
Very slight erythema was noted in 2 treated skin sites 1 hour after patch removal. All treated skin sites appeared normal at the 24-hour observation. - Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- The skin irritancy potential of the test material was assessed according to OECD guideline 404. The test material produced a primary irriation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP). - Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion) and Method B4 of Commission Directive 92/69/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of 3 rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation.
The test material produced a primary irritation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-03-17 to 1988-03-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was carried out to generally valid and internally-accepted guidelines and performed according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamstead, Hertfordshire
- Age at study initiation: 12 weeks
- Weight at study initiation: approx 2.0 kg
- Housing: Individually housed in grid-bottomed metal cages.
- Diet: SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex, ad libitum (antibiotic free)
- Water: mains drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 20°C.
- Humidity: 44-77%.
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light (fluorescent lighting) - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- (distilled)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g material mixed with 0.5 ml distilled water
VEHICLE
- distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days (observations at 1 hr, 24 hr, 48 hr, 72 hr, 7 days)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: lint pad; held in place with 7.5 cm width elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: With cotton wool soaked in water warmed to approx. 37 °C.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the assessment of colour) and irritation allocated a numerical value based on the following:
Erythema and Eschar formation:
0 - No erythema:
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well defined by definite raising)
3 - Moderate oedema (raised approximately 1mm)
4 - Severe oedema (raised more than 1mm and extending beyond area of exposure)
Other signs of reaction to treatment such as systematic effects were recorded. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 769
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 773
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 774
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 769
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 773
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 774
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritant / corrosive response data:
- No irritation or corrosion to any test animal was recorded at any time.
- Other effects:
- No other local or systemic effects.
- Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- No irritation was apparent in any animal during the course of the study. It is concluded that Gel All MD is not an irritant to rabbit skin.
- Executive summary:
The purpose of the study was to assess the skin irritation potential of Gel All MD in rabbits.
The method used was designed to meet the requirements of OECD Guideline No. 404.
Gel All MD, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.
No skin irritation was observed in any animal at any assessment.
It was concluded that Gel All MD is not irritant to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5, CAS 87826-41-3)
Taget chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13. - Reason / purpose for cross-reference:
- read-across source
- Amount / concentration applied:
VEHICLE
- distilled water- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 769
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 773
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 774
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 769
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 773
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 774
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritation at any observation
- Irritant / corrosive response data:
- No irritation or corrosion to any test animal was recorded at any time.
- Other effects:
- No other local or systemic effects.
- Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- No irritation was apparent in any animal during the course of the study. It is concluded that Gel All MD is not an irritant to rabbit skin.
- Executive summary:
The purpose of the study was to assess the skin irritation potential of Gel All MD (EC 402-950-5) in rabbits.
The method used was designed to meet the requirements of OECD Guideline No. 404.
Gel All MD, moistened with water, was applied for four hours under a semi-occlusive dressing to the clipped dorsal skin of three rabbits. Assessments for skin irritation were made 1, 24, 48 and 72 hours and 7 days after removal of the dressing.
No skin irritation was observed in any animal at any assessment.
It was concluded that Gel All MD is not irritant to rabbit skin.
It is proposed that this result can be used in the assessment of the target substance (EC 406-176-9).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC 413-110-2, CAS 135861-56-2)
Taget chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13. - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 2 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 27 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No erythema/eschar observed at any observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (Animal 167 - female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 2 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 27 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (Animal 167 - female)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No edema observed at any observation
- Irritant / corrosive response data:
- Very slight erythema was noted in 2 treated skin sites 1 hour after patch removal. All treated skin sites appeared normal at the 24-hour observation.
- Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- The skin irritancy potential of the test material was assessed according to OECD guideline 404. The test material produced a primary irriation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP). - Executive summary:
A study was performed to assess the irritancy potential of the test material (EC 413-110-2) to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion) and Method B4 of Commission Directive 92/69/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of 3 rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation.
The test material produced a primary irritation of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material does not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No. 1272/2008 (CLP).
It is proposed that this result can be used in the assessment of the target substance (EC 406-176-9).
Referenceopen allclose all
Irritation endpoint |
Mean Score |
Maximum Value Observed |
Maximum Duration of any Effect |
Maximum value at the end the observation period |
Erythema/eschar |
0 |
0 |
- |
0 |
Oedema |
0 |
0 |
- |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg - Duration of treatment / exposure:
- Single application
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects at any time poiint
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects at any time point
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 4 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 5 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects at any time point
- Irritant / corrosive response data:
- No adverse effects were observed for the iris or corneal damage at any time point in any animal.
Minor conjuncitval irritation (redness) was observed in 4 animals and resolved within 1 day.
Minor chemosis was observed in 1 animals and resolved within 1 day. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No adverse effects were observed for the iris or corneal damage at any time point in any animal.
Minor conjuncitval irritation (redness) was observed in 4 animals and minor chemosis was observed in 1 animal. All eyes were normal after 1 day.
A single application of test material into the rabbit eye did not produce a positive response according to CLP criteria. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 1997 to 19 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.54 to 2.75 kg
- Housing: animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16- 19 °C
- Humidity (%): 55- 74 %
- Air changes (per hr): 15 changes per hr
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): volume 0.1 mL , which was found to weigh approximately 41 mg - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- One rabbit was initially treated. A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about 1 s immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, 2 additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 h and 24, 48 and 72 h following treatment, according to the Draize scale for scoring ocular irritation.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No corneal effects at any observation in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial effects at any observation in any animal
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 1 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 14 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 15 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 1 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 14 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 15 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Tables 1 and 2 (attached background material). The individual means scores are presented in Table 3 (attached background material).
Residual test material was noted around 1 treated eye at the 1-hour observation but did not prevent an evaluation of the ocular responses.
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes 1 h after treatment with minimal conjunctival irritation at the 24-hour observation. Minimal conjunctival persisted in 1 treated eye at the 48-hour observation.
Treated eyes appeared normal at the 48 or 72-hour observations. - Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- The eye irritancy potential of the test material was assessed according to OECD guideline 405.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce postive criteria in any rabbit according to Regulation (EC) No. 1272/2008 (CLP). - Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC.
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Treated eyes appeared normal at the 48 or 72-hour observations.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to Regulation (EC) No. 1272/2008 (CLP).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 1988 to 13 June 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 24 February 1987)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Healthy female rabbits were obtained from Goreside Rabbits, Northchurch, Berkhamsted, Hereford
- Age at study initiation: At receipt the animals were 8 weeks of age, but left to acclimatise for at least 9 days.
- Weight at study initiation: See table.
- Housing: The rabbits were individually housed in grid-bottomed metal cages.
- Diet (e.g. ad libitum): A commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex), ad libitum.
- Water (e.g. ad libitum): Mains drinking water via an automatic nozzle, ad libitum.
- Acclimation period: At least 9 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): Relative humidity within the range 44 - 77%.
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was controlled to give an artificial cycle of 12 hours light/12 hours dark per day. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of the supplied material (weighing approximately 30 mg)
- Duration of treatment / exposure:
- Single exposure with observation for 7 days
- Observation period (in vivo):
- One, 24, 48 and 72 hours and 7 days following instillation of the test material the animals eyes were examined macroscopically under a standard light source.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- One restrained rabbit was dosed initially to assess the severity of any irritant response. As no marked irritation was seen a further two restrained animals were dosed, bringing the group size to three.
The test material was instilled into the right eye of each restrained animal by gently pulling away the lower lid from the eyeball to form a cup into which the test material was placed. The lids were then held shut for a few seconds. The treated eyes of the rabbits were not rinsed after dosing. The left eye was untreated and served as a control. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritant / corrosive response data:
- One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours.
- Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- Slight to moderate conjunctival irritancy (redness) was observed up to 24 hours post-installation.
- Executive summary:
The purpose of the study was to assess the eye irritation potential of Gel All MD in rabbits.
The method used was designed to meet the requirements of OECD Guideline No. 405.
Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.
One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.
The slight irritation (redness) was fully reversible and not sufficient for classification.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC 413-110-2, CAS 135861-56-2)
Taget chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13. - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No corneal effects at any observation in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial effects at any observation in any animal
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 1 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 14 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (Animal 15 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 1 - male)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 14 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal 15 - male)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Score of 1 at 1 hour observation
- Irritant / corrosive response data:
- Residual test material was noted around 1 treated eye at the 1-hour observation but did not prevent an evaluation of the ocular responses.
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes 1 h after treatment with minimal conjunctival irritation at the 24-hour observation. Minimal conjunctival persisted in 1 treated eye at the 48-hour observation.
Treated eyes appeared normal at the 48 or 72-hour observations. - Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- The eye irritancy potential of the test material was assessed according to OECD guideline 405.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce postive criteria in any rabbit according to Regulation (EC) No. 1272/2008 (CLP). - Executive summary:
A study was performed to assess the irritancy potential of the test material (EC 413-110-2) to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC.
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Treated eyes appeared normal at the 48 or 72-hour observations.
The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to Regulation (EC) No. 1272/2008 (CLP).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5, CAS 87826-41-3)
Taget chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13, - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 781)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 777)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (Animal No 778)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iris effects observed at any observation
- Irritant / corrosive response data:
- One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours.
- Interpretation of results:
- other: not irritating
- Remarks:
- Not classified as irritant according to CLP.
- Conclusions:
- Slight to moderate conjunctival irritancy (redness) was observed up to 24 hours post-installation.
- Executive summary:
The purpose of the study was to assess the eye irritation potential of Gel All MD (EC 402-950-5) in rabbits.
The method used was designed to meet the requirements of OECD Guideline No. 405.
Gel All MD was instilled into the right eye of three rabbits. Assessments of eye irritation were made 1, 24, 48 and 72 hours and 7 days after installation.
One hour after instillation, well defined conjunctival redness was seen in two rabbits and slight redness in the third animal. Only slight conjunctival redness was seen after 24 hours in two animals. All eyes were normal within 48 hours. No chemosis, iridial irritation or cornea effects were observed.
The slight irritation (redness) was fully reversible and not sufficient for classification.
Referenceopen allclose all
Endpoint |
Mean score |
Maximum value |
Maximum duration of any effect |
Maximum value at the end of observation period |
Conjunctivae / redness |
1 in 4 animals 0 in 2 animals |
1 in 4 animals |
1 day |
0 |
Chemosis |
1 in 1 animal 0 in 5 animals |
1 in 1 animal |
1 day |
0 |
Cornea |
0 |
0 |
- |
0 |
Iris |
0 |
0 |
- |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of skin irritation studies, the substance is not an irritant to skin. The substance is therefore not classification according to EU CLP regulation as a corrosive or skin irritant.
Based on the result of an in-vivo eye irritation studies, the substance does not cause serious eye damage or irritation. The substance is therefore not classified according to EU CLP regulation as irritating to eyes.
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