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EC number: 279-255-7 | CAS number: 79770-29-9
- 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
The substance is not irritating to the rabbit skin or eyes.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (non-GLP, 24-hour occlusive exposure, TS conc. 50% in vehicle)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline (§ 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- other: polyethylene glycol (PEG 400) + saline 0.9 % (70 : 30 parts)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on back and flank
- Type of wrap if used: impermeable
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact skin. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test material is not irritating to the rabbit skin.
- Executive summary:
The test item contained 89% active ingredient and 10% urea and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin only. Erythema could not be assessed due to the coloration by the dye.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
- Principles of method if other than guideline:
- According to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: 3-minutes exposure: male 2.95 kg, female: 3.57 kg; 4-hours exposure: male 2.95 kg, female: 3.57 kg
- Housing: single housing in stainless steel cages with wire mesh walk flaar, floor area: 40 cm x 51 cm
- Diet: about 130 g per animal per day (Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG)
- Water: about 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: about 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -26
- Humidity (%): about 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipping of fur at least 15 hours before beginning of study
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Dipping of the test patch (2.5 cm x 2.5 cm) in the undiluted substance, and thus about 0.5 ml of the test liquid is absorbed.
- Concentration: undiluted - Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 8 days
- Number of animals:
- 2 (1 male + 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on upper third of the back or flank
- Type of wrap if used: occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1 :1)
- Time after start of exposure: 3 minutes or 4 hours
SCORING SYSTEM: Draize scores - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Erythema scores could not be read because of staining due to the test substance.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 3-minutes exposure: No erythema or edema.
4-hour exposure: Erythema scores could not be read because of staining due to the test substance. No edema occured. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The TS is considered to be not irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP, 24-hour occlusive exposure, TS conc. 50% in vehicle)
- Principles of method if other than guideline:
- Patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Fullinsdorf, Switzerland
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14 / 10 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- other: propylene glycol + saline (70 : 30 parts)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on back and flank
- Type of wrap if used: impermeable
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact and scarified skin.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The TS was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
The test item contained 67% active ingredient and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24 h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. No erythema and no edema were noted at any observation time.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with detailed documentation (non-GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2300 - 2420 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet ad libitum (Nafag No. 814, Gossau, Switzerland)
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (because no reactions were observed at 24 hours to 72 hours after removing the bandages)
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 20 cm² on flank
- Type of wrap if used: The patches were loosely covered with an aluminium foil (36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
SCORING SYSTEM: OECD scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No reactions were observed at 24 hours to 72 hours after removing the bandages.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- It can be concluded thatthe TS has no primary skin irritant potency in albino rabbits.
- Executive summary:
The test item contained 20% active ingredient, 79% water and 1% TEA-HCl buffer. Three male albino rabbits were treated with 0.5 ml in a gauze patch of 20 cm². The patches were covered with aluminium foil and held in place for four hours with adhesive tape. Skin reactions were observed 1, 24, 48 and 72 hours after patch removal. No erythema or edema were noted at any observation time point.
Referenceopen allclose all
Individual cutaneous examinations and mean values (24-hour exposure, occlusive, intact skin):
Readings |
Animal |
Exposure period: 24 h, occlusive |
|
Erythema |
Edema |
||
24 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
48 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
Mean (24, 48, 72 h) |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
04 |
0 |
0 |
|
05 |
0 |
0 |
|
06 |
0 |
0 |
|
Mean (24, 48, 72 h) |
|
0.0 |
0.0 |
Response data, exposure period 4 hours, occlusive:
Reading |
Animal |
Intact Skin |
|
Erythema |
Edema |
||
24 h |
1 |
* |
0 |
2 |
* |
0 |
|
48 h |
1 |
* |
0 |
2 |
* |
0 |
|
8 d |
1 |
* |
0 |
2 |
0 |
0 |
* assessment could not be made because of staining due to the test substance
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (non-GLP)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline (§ 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 30 seconds (rinsed) or unspecified (unrinsed)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritant / corrosive response data:
- The TS was found to cause a minimal irritation when applied to the rabbit eye mucosa. Irritation was fully reversible within 72 hours. When the application site was rinsed, no irritation was found.
- Other effects:
- During the whole observation period parts of the cornea and sclera were reddish stained.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa and no irritation when the application site was rinsed. Taken together, the test material is considered to be not irritating to the eye.
- Executive summary:
The test item contained 89% active ingredient and 10% urea. Three male and female New Zealand rabbits were treated with 0.1 g by insertion into the conjunctival sac of the left eye. The lids were gently closed for a few seconds. In three of the rabbits, the treated eye was flushed with 10 ml of physiological saline after ca. 30 seconds. The eye irritation was assessed after 1, 2, 3, 4 and 7 days. Only in non-rinsed eyes, redness, chemosis and discharge were observed on the first and second day. These findings were no longer noted on the third day. During the whole observation period, parts of the cornea and sclera were reddish stained.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (non-GLP)
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019 of Sept. 27, 1973
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: mean males 3.32 kg, mean females: 2.69 kg
- Housing: single housing in stainless steel cages with wire mesh walk flaar, floor area: 40 cm x 51 cm
- Diet: about 130 g per animal per day (Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG)
- Water: about 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: about 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -26
- Humidity (%): about 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- unspecified (no removal of TS by washing)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: according to Draize - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.05
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.15
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- See table below.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The TS is considered to be not irritating to the eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP)
- Principles of method if other than guideline:
- Test for eye irritants described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Fullinsdorf, Switzerland
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14 / 10 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 30 seconds (rinsed) or unspecified (unrinsed)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: rinsed
- Irritant / corrosive response data:
- The TS was found to cause a minimal irritation when applied to the rabbit eye mucosa. Irritation was fully reversible within 48 hours. Rinsing the eyes following instillation was of no effect.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa. Irritation was fully reversible within 48 hours. Rinsing the eyes following instillation was of no effect. Taken together, the test material is considered to be not irritating to the eye.
- Executive summary:
The test item contained 67% active ingredient. Three male and female New Zealand rabbits were treated with 0.1 g by insertion into the conjunctival sac of the left eye. The lids were gently closed for a few seconds. In three of the rabbits, the treated eye was flushed with 10 ml of physiological saline after ca. 30 seconds. The eye irritation was assessed after 1, 2, 3, 4 and 7 days. In both rinsed and non-rinsed eyes, redness, chemosis and discharge were observed on the first day. These findings were no longer noted on the second day. No other findings were noted at any observation time.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with detailed documentation (non-GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2450 - 2480 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet ad libitum (Nafag No. 814, Gossau, Switzerland)
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: according to OECD guideline
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 ,48, 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Slight redness of the conjunctiva was noted after 1h and 24h. The mean score was 0.0, 0.0, 0.33 and 0.0 for cornea, iris, conjunctivae and chemosis, respectively. The eye reactions observed were fully reversible until the end of the observation period on day 3.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions employed the TS induced very slight irritation of the conjunctiva when applied into the conjunctival sac of albin rabbits. The eye reactions observed were fully reversible until the end of the observation period on day 3. Taken together, the TS is considered to be not irritating to the eye.
- Executive summary:
The test item contained 20% active ingredient, 79% water and 1% TEA-HCl buffer. One eye of each three male rabbits was treated with 0.1 ml. Slight redness of the conjunctiva was noted after 1h and 24h. The mean score was 0.0, 0.0 and 0.33 for cornea, iris and conjunctiva, respectively. The eye reactions observed were fully reversible until the end of the observation period on day 3.
Referenceopen allclose all
Individual ocular examinations and mean values, unrinsed eyes (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
24 h |
01 |
0 |
0 |
0 |
2 |
1 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
1 |
1 |
1 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
1 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.7 |
0.3 |
|
02 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
03 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
|
Mean |
|
0.0 |
|
0.0 |
0.4 |
0.2 |
|
Individual ocular examinations and mean values, rinsed eyes (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
24 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
02 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
03 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
Mean |
|
0.0 |
|
0.0 |
0.0 |
0.0 |
|
Individual ocular examinations and mean values (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
24 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
04 |
0 |
0 |
0 |
0* |
0 |
0 |
|
05 |
0 |
0 |
0 |
0* |
0 |
0 |
|
06 |
0 |
0 |
0 |
0* |
0 |
0 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
1 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
04 |
0 |
0 |
0 |
1 |
0 |
0 |
|
05 |
0 |
0 |
0 |
1 |
0 |
0 |
|
06 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
04 |
1 |
1 |
0 |
0 |
0 |
0 |
|
05 |
0 |
0 |
0 |
0 |
0 |
0 |
|
06 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
02 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
03 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
04 |
0.3 |
|
0.0 |
0.3 |
0.0 |
|
|
05 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
06 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
Mean |
|
0.05 |
|
0.0 |
0.15 |
0.0 |
|
* If at one reading assessments referring to the same characteristic cannot be made in 1 – 5 animals, the mean of the specific values rounded to the nearest whole number that could be read was inserted instead.
Individual ocular examinations and mean values, unrinsed eyes (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
24 h |
01 |
0 |
0 |
0 |
1 |
1 |
1 |
02 |
0 |
0 |
0 |
1 |
2 |
1 |
|
03 |
0 |
0 |
0 |
1 |
1 |
1 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
02 |
0.0 |
|
0.0 |
0.3 |
0.7 |
|
|
03 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
|
Mean |
|
0.0 |
|
0.0 |
0.3 |
0.4 |
|
Individual ocular examinations and mean values, rinsed eyes (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
24 h |
01 |
0 |
0 |
0 |
1 |
1 |
2 |
02 |
0 |
0 |
0 |
1 |
1 |
1 |
|
03 |
0 |
0 |
0 |
1 |
1 |
1 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
02 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
|
03 |
0.0 |
|
0.0 |
0.3 |
0.3 |
|
|
Mean |
|
0.0 |
|
0.0 |
0.3 |
0.3 |
|
Individual ocular examinations and mean values (24, 48, 72 hours):
Readings |
Animal |
Cornea opacity |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 h |
01 |
0 |
0 |
1 |
1 |
02 |
0 |
0 |
1 |
1 |
|
03 |
0 |
0 |
1 |
1 |
|
24 h |
01 |
0 |
0 |
1 |
0 |
02 |
0 |
0 |
1 |
0 |
|
03 |
0 |
0 |
1 |
1 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
0.0 |
0.3 |
0.0 |
02 |
0.0 |
0.0 |
0.3 |
0.0 |
|
03 |
0.0 |
0.0 |
0.3 |
0.3 |
|
Mean |
|
0.0 |
0.0 |
0.3 |
0.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A pre-GLP study according to EPA guideline (§ 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978) was performed (Ciba 801995 (1980)). The test item contained 89% active ingredient and 10% urea and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin only. Erythema could not be assessed due to the coloration by the dye. The test material is not irritating to the rabbit skin.
In support of this study several other studies are available. Firstly, in a study by CIBA-Geigy Ltd.(Ciba 785731 (1979)), according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics; US Association of Food and Drug Officials), the test item (which contained 67% active ingredient) was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24 h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. No erythema and no edema were noted at any observation time.
Secondly, CIBA-Geigy Ltd.(Ciba 875185 (1987)) conducted a study according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) but not in compliance with GLP. The test item contained 20% active ingredient, 79% water and 1% TEA-HCl buffer. Three male albino rabbits were treated with 0.5 ml in a gauze patch of 20 cm². The patches were covered with aluminium foil and held in place for four hours with adhesive tape. Skin reactions were observed 1, 24, 48 and 72 hours after patch removal. No erythema or edema were noted at any observation time point.
Thirdly, BASF AG 81/115 (1981) performed a study according to J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health. The study was not performed in compliance with GLP. Three rabbits (1 male and 2 females) were used in this study. The backs of the rabbits were shaved (2.5 x 2.5 cm). Test patches (2.5 x 2.5 cm) were loaded with undiluted test material (containing 14.5% active ingredient, 83% water, 1.5% NPG and 1% salts) and covered with an occlusive dressing. The material was removed by washing 3 minutes and 4 hours after application. No effect was found on edema but unfortunately erythema could not be scored due to red staining by the test substance.
Eye irritation:
A pre-GLP study according to EPA guideline (§ 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978) was conducted (Ciba 801994 (1981)). The test item contained 89% active ingredient and 10% urea. Three male and female New Zealand rabbits were treated with 0.1 g by insertion into the conjunctival sac of the left eye. The lids were gently closed for a few seconds. In three of the rabbits, the treated eye was flushed with 10 ml of physiological saline after ca. 30 seconds. The eye irritation was assessed after 1, 2, 3, 4 and 7 days. Only in non-rinsed eyes, redness, chemosis and discharge were observed on the first and second day. These findings were no longer noted on the third day. During the whole observation period, parts of the cornea and sclera were reddish stained. Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa and no irritation when the application site was rinsed. Taken together, the test material is considered to be not irritating to the eye.
In support of this conclusion several studies are available. A pre-GLP study (Ciba 785730 (1979)) was performed according to Test for eye irritants described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test item contained 67% active ingredient. Three male and female New Zealand rabbits were treated with 0.1 g by insertion into the conjunctival sac of the left eye. The lids were gently closed for a few seconds. In three of the rabbits, the treated eye was flushed with 10 ml of physiological saline after ca. 30 seconds. The eye irritation was assessed after 1, 2, 3, 4 and 7 days. In both rinsed and non-rinsed eyes, redness, chemosis and discharge were observed on the first day. These findings were no longer noted on the second day. No other findings were noted at any observation time. Under the conditions of this study, the substance was not irritating to the eye.
The second supporting study, non-GLP, (Ciba 875184 (1987)) was performed according to OECD TG 405. Three male albino rats were treated with 0.1 mL undiluted test substance (which contained 20% active ingredient). The untreated eye of the same animal served as control. Eye irritation was assessed at 1, 24, 48 and 72 hours after application. The substance induced very slight irritation of the conjunctiva (slight redness at 1 hr and 24 hr, mean score 0.33). The eye reactions observed were fully reversible until the end of the observation period on day 3. Under the conditions of this study, the substance was not irritating to the eye.
The third non-GLP supporting study (Ciba 81/115 (1981)) was performed according to Fed. Reg. 38, No. 187, § 1500.42, p. 27019 of Sept. 27, 1973. Three male and three female Vienna white rabbits were treated with 0.1 mL undiluted test substance (which contained 14.5% active ingredient, 83% water, 1.5% NPG and 1% salts); the untreated eye of the same animal served as control. Eye irritation was assessed at 24, 48 and 72 hours after application. The substance induced slight redness of the conjunctivae at 48 hours in three rabbits and slight corneal opacity in one rabbit at 72 hours (last observation time point). Under the conditions of this study, the substance was not irritating to the eye.
Justification for classification or non-classification
The test substance does not have to be classified for skin and eye irritation to according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.