Registration Dossier
Registration Dossier
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EC number: 430-710-1 | CAS number: 15290-77-4
Endpoint summary
Administrative data
Description of key information
Skin irritation:
The skin irritation potential of test item to the rabbit was assessed by EPA OTS 798.4470. A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.
Eye irritation:
The eye irritation potential of test item to the rabbit was assessed following EPA OTS 798.4500. A single instillation of test item into the eye of the rabbit elicited transient, very slight to moderate conjunctivaI irritation.
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:
- From 1997-08-27 to 1997-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Version / remarks:
- September 27, 1985
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch No.: 9705-2A
Purity:> 97% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 13 to 24 weeks
- Weight at study initiation: 3.0 to 4.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 49-71
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- liquid substance administered as supplied
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL to each site.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- Coverage: covered with "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal reactions were observed in any animal throughout the study
- Other effects:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period. - Interpretation of results:
- other: Not classified
- Conclusions:
- A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.
- Executive summary:
A study was performed to assess the skin irritation potential of test item to the rabbit following EPA OTS 798.4470. Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for four days.
There were no signs of toxicity or ill health in any rabbit during the observation period.
No dermal reactions were observed in any animal throughout the study
A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.
Reference
Dermal reactions individual scores:
No. |
Erythema |
Oedema |
||||
24h |
48h |
72 h |
24h |
48h |
72 h |
|
2313 |
0 |
0 |
0 |
0 |
0 |
0 |
2314 |
0 |
0 |
0 |
0 |
0 |
0 |
2315 |
0 |
0 |
0 |
0 |
0 |
0 |
2316 |
0 |
0 |
0 |
0 |
0 |
0 |
2317 |
0 |
0 |
0 |
0 |
0 |
0 |
2318 |
0 |
0 |
0 |
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:
- From 1997-09-01 to 1997-09-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- Sep 27, 1985
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch No.: 9705-2A
Purity: 98.18 % - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 10 to 16 weeks
- Weight at study initiation: 2.4 to 3.6 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20.5
- Humidity (%): 57-75
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 4 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TREATMENT PROCEDURE
The eyes of each animal were examined prior to instillation to ensure that there was no pre-existing corneaI damage, iridial or conjunctival inflammation.
One animal was treated in advance of the other five, to ensure that if a severe response was produced, no further animals would be exposed. Approximately 0.1 mL of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: handheld light - Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 & #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3 & #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed.
Diffuse beefy to crimson red colouration of the conjunctivae was seen in three animals at the one hour time point. Transient hyperaemia was observed in the remaining three animals. In addition, swelling was seen in two animals. These reactions had resolved in all instances by 1, 2 or 4 days after instillation. No corneal damage or irridial inflammation was observed - Other effects:
- - Clinical observations:
There were no signs of toxicity or ill health in any rabbit during the observation period. - Interpretation of results:
- other: Not classified
- Conclusions:
- A single instillation of test item into the eye of the rabbit elicited transient, very slight to moderate conjunctivaI irritation.
- Executive summary:
A study was performed to assess the eye irritation potential of test item to the rabbit following EPA OTS 798.4500. Six rabbits were each administered a single ocular dose of 0.1 mL of the test substance and observed for up to four days after instillation.
There were no signs of toxicity or ill health in any rabbit during the observation period.
No corneal damage or iridial inflammation was observed.
Diffuse beefy to crimson red colouration of the conjunctivae was seen in three animals at the one hour time point. Transient hyperaemia was observed in the remaining three animals. In addition, swelling was seen in two animals. These reactions had resolved in all instances by 1, 2 or 4 days after instillation. No corneal damage or irridial inflammation was observed.
A single instillation of test item into the eye of the rabbit elicited transient, very slight to moderate conjunctivaI irritation.
Reference
Ocular reactions:
No. |
Conjunctivae |
Chemosis |
Cornea opacity |
Iris |
||||||||||||
24h |
48h |
72h |
Mean |
24h |
48 h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
|
1 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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
Skin irritation:
In vivo, EPA OTS 798.4470:
Mean scores at 24, 48 and 72 hours after patch removal: erythema: 0 for all animals tested;
oedema: 0 for all animals tested.
According to Regulation (EC) No 1272/2008, section 3.2.2.1 and Table 3.2.2, this substance should not be classified for this endpoint.
Eye irritation:
In vivo, EPA OTS 798.4500:
Mean scores at 24, 48 and 72 hours after treatment:
Conjunctivae: 0.33, 0, 0, 1, 0.33, 0;
Chemosis: 0, 0, 0, 0, 0, 0;
Cornea opacity: 0, 0, 0, 0, 0, 0;
Iris: 0, 0, 0, 0, 0, 0.
According to Regulation (EC) No 1272/2008, table 3.3.1 and 3.3.2, this substance should not be classified for this endpoint.
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.
