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EC number: 689-188-9 | CAS number: 149343-84-0
- 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/corrosion
The test material was classified as non-irritant.
Eye irritation
The test material was classified as non-irritant.
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:
- 26 May 1993 to 2 June 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Method B4 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Specification
Three New Zealand White rabbits were supplied by David Percival ltd., Moston, Sandbach, Cheshire, U.K. At the start of the study the animals weighed 2.45 - 2.74 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
Husbandry
The animals were individually housed in suspended metal cages.
Free access to mains drinking water and food. (RABMA Rabbit Diet, Special Diet Services ltd., Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 18 – 23 °c and relative humidity of 51 - 65%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give continuous 12 hours light and 12 hours darkness. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
Any other skin reactions, if present, were also recorded.
An additional observation was made on day 7 to assess the reversibility of skin reactions . - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal.
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites one hour after patch removal and at all treated skin sites at the 24, 48 and 72-hour observation. The erythema extended beyond all treated skin sites during this time.
Very slight oedema was noted at one treated skin site at the 24 and 48-hour observations.
Desquamation was noted at all treated skin sites seven days after treatment. - Other effects:
- Light blue-coloured staining caused by the test material was noted at all treated skin sites following patch removal. The staining did not affect evaluation of skin responses.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, JPR BLUE 100, produced a primary irritation index of 1.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as NON IRRITANT to rabbit skin. No symbol and risk phrase are therefore required. - 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 that described in the OECD Guidelines for Testing of Chemicals {1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 92/ 69/ EEC {which constitutes Annex V of Council Directive 67/ 548/ EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/ EEC {as adapted to technical progress by Commission Directive 91/325/EEC} .
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Desquamation was noted at all treated skin sites seven days after treatment.
The test material produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material was also classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required.
Reference
JPR BLUE 100: ACUTE DERMAL IRRITATION TEST IN THE RABBIT
INDIVIDUAL SKIN REACTIONS
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex (Bodyweight Kg) |
Total |
||
198 Female (2.74) |
202 Male (2.45) |
203 Female (2.45) |
|||
Erythema/Eschar Formation |
1 Hour 24 Hours 48 Hours 72 Hours 7 Days |
1 STA 1 RSTA 1 RSTA 1 STA 0 DSTA |
1 STA 1 RSTA 1 RSTA 1 STA 0 DSTA |
0 STA 1 RSTA 1 RSTA 1 RSTA 0 DSTA |
(2) 2 (3) 3 (0) |
Oedema Formation |
1 Hour 24 Hours 48 Hours 72 Hours 7 Days |
0 0 0 0 0 |
0 1 1 0 0 |
0 0 0 0 0 |
(0) 1 (1) 0 (0) |
Sum of 24 and 72-Hour Readings (S) |
7 |
||||
Primary Irritation Index (S/6) |
7/6 = 1.2 |
||||
Classification |
MILD IRRITANT |
( ) = Total values not used for calculation of primary irritation index
D = desquamation
STA = light blue-coloured staining
R = reaction extends beyond treatment site
INDIVIDUAL DAILY AND INDIVIDUAL MEAN SCORES FOR DERMAL IRRITATION FOLLOWING 4-HOUR EXPOSURE REQUIRED FOR EEC LABELLING REGULATIONS
Skin Reaction |
Reading (Hours) |
Individual Scores –Rabbit Number and Sex (Bodyweight Kg) |
||
198 Female (2.74) |
202 Male (2.45) |
203 Female (2.45) |
||
Erythema/Eschar Formation |
24 48 72 |
1 1 1 |
1 1 1 |
1 1 1 |
Total |
|
3 |
3 |
3 |
Mean Score |
|
1.0 |
1.0 |
1.0 |
Oedema Formation |
24 48 72 |
0 0 0 |
1 1 0 |
0 0 0 |
Total |
|
0 |
2 |
0 |
Mean Score |
|
0.0 |
0.7 |
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:
- 2 June 1993 to 6 June 1993.
- 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:
- OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion"
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Method B5 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Specification
Three New Zealand White rabbits were supplied by David Percival Ltd., Maston, Sandbach, Cheshire, U.K. At the start of the study the animals weighed 2.61 - 3.09 g, and were approximately twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on a cage label.
Husbandry
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 23 °C and relative humidity of 58 - 66 %. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approx imately 99 mg.
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope.
Animals showing evidence of ocular lesions were rejected and replaced.
One rabbit was initially treated. A volume of 0.1 ml of the test material, which was found to weigh approximately 99 mg (as measured by gently compacting the required volume into an adapted syringe) 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 one second 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, two additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic ("Ophthaine", 0.5% proxymetacaine hydrochloride, E.R. Squibb & Sons , Limited Hounslow, Middlesex, U.K.) was instilled into both eyes of these animals 1 - 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
Any other ocular effects were also noted. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- 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:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation at the 24-hour observation. Minimal conjunctival redness was noted in one treated eye at the 48-hour observation.
No ocular effects were noted 72 hours after treatment. - Other effects:
- Residual test material was noted around the treated eye of all animals throughout the study.
Blue-coloured staining was noted in all treated eyes throughout the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, JPR BLUE 100, produced a maximum group mean score of 12.7 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 the EEC labelling regulations and was classified as NON IRRITANT to the rabbit eye. No symbol and risk phrase are therefore required. - 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 (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. No ocular effects were noted 72 hours after treatment.
The test material produced a maximum group mean score of 12.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the Kay and Calandra classification system.
The test material was also classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required.
Reference
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL SCORES AND INDIVIDUAL TOTAL SCORES FOR OCULAR IRRITATION
Rabbit Number and Sex (Bodyweight Kg) |
IPR = 3 |
IPR = 0 + |
IPR = 0 + |
|||||||||
151 Female (3.09) |
154 Male (2.61) |
165 Female (2.83) |
||||||||||
Time After Treatment |
1 hr |
24 hr |
48 hr |
72 hr |
1 hr |
24 hr |
48 hr |
72 hr |
0 hr |
24 hr |
48 hr |
72 hr |
CORNEA E = Degree of Opacity F = Area of Opacity |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
0S 0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS D |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
0S |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2S 2 2Re |
1S 1 0Re |
0S 0 0Re |
0S 0 0Re |
2S 2 3Re |
2S 1 0Re |
1S 0 0Re |
0S 0 0Re |
2S 2 2Re |
1S 1 0Re |
0S 0 0Re |
0S 0 0Re |
Score (A + B + C) x 2 |
12 |
4 |
0 |
0 |
14 |
6 |
2 |
0 |
12 |
4 |
0 |
0 |
Total Score |
12 |
4 |
0 |
0 |
14 |
6 |
2 |
0 |
12 |
4 |
0 |
0 |
Key: hr = hour(s) IPR = initial pain reaction Re = residual test material around treated eye
+ = one drop of Ophthaine instilled into each eye 1 – 2 minutes before dosing S = blue coloured staining
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL TOTAL SCORES AND GROUP MEAN SCORE FOR OCULAR IRRITATION
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
151 Female 154 Male 165 Female |
12 14 12 |
4 6 4 |
0 2 0 |
0 0 0 |
Group Total |
38 |
14 |
2 |
0 |
Group Mean Score |
12.7 1 Hour |
4.7 24 Hours |
0.7 48 Hours |
0.0 72 Hours |
JPR BLUE 100: ACUTE EYE IRRITATION TEST IN THE RABBIT
INDIVIDUAL & MEAN SCORES FOR CORNEA, IRIS & CONJUNCTIVAE REQUIRED FOR EEC LABELLING REGULATIONS
Rabbit Number & Sex (Bodyweight Kg) |
Time After Treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
151 Female (3.09) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Total |
|
0 |
0 |
1 |
1 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.3 |
154 Male (2.61) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
2 1 0 |
1 0 0 |
Total |
|
0 |
0 |
3 |
1 |
Mean |
|
0.0 |
0.0 |
1.0 |
0.3 |
165 Female (2.83) |
24 Hours 48 Hours 72 Hours |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Total |
|
0 |
0 |
1 |
1 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/Corrosion
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Desquamation was noted at all treated skin sites seven days after treatment.
The test material produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material was classified as non-irritant.
Eye irritation
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit.
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. No ocular effects were noted 72 hours after treatment.
The test material produced a maximum group mean score of 12.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the Kay and Calandra classification system.
The test material was classified as non-irritant.
Justification for classification or non-classification
Skin irritation/corrosion
The test material was classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required.
Eye irritation
The test material was classified as non-irritant according to EEC labelling regulations. No symbol and risk phrase are required.
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.