Registration Dossier
Registration Dossier
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EC number: 229-158-0 | CAS number: 6420-33-3
Endpoint summary
Administrative data
Description of key information
In a test according to OECD 404 3 rabbits were exposed dermally to the substance under semi-occlusion for 4 hours. No signs of irritation were observed at the 1, 24, 48 and 48 hour observations. A slight yellow staining of the skin was seen. The substance is not irritant to the skin (Safepharm 1985).
In a test according to OECD 405 3 rabbits received 0.1 mL of the substance in the eye. Initial signs of irritation were fully reversible over the 72 hour (7 day) observation period. The substance is considered not irritating to the eyes (Safepharm 1985).
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:
- 29 October 1985 to 1 November 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.36-3.36 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-58%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch wrapped with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water moistened cotton wool and thereafter with ether
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: at 1 hour 24, 48 and 72 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible
- 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 irritant effects
- Other effects:
- faint yellow staining of the skin was observed, that did not prevent erythema scoring
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritant to the skin
- Executive summary:
In a test according to OECD 404 3 rabbits were exposed dermally to the substance under semi-occlusion for 4 hours. No signs of irritation were observed at the 1, 24, 48 and 48 hour observations. A slight yellow staining of the skin was seen. The substance is not irritant to the skin.
Reference
| Animal | 1 | 2 | 3 | |||||||||
| 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | 24 | 48 | 72 | ||
| erythema | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| oedema | 0 | 0 | 0 | 0 | 0 | 0 | 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:
- 4 November 1985 to 11 November 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.54-3.12 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-55%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (48 mg)
- Observation period (in vivo):
- at 1, 24, 48, 72 hours and at day 7 (one rabbit only)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- at the 1 hour observation dulling of the cornea was observed in all 3 rabbits
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- one animal reversible within 7 days others within 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no irritation observed
- Other effects:
- at the 1 hour observation dulling of the cornea was seen and areas of yellow staining
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes
- Executive summary:
In a test according to OECD 405 3 rabbits received 0.1 mL of the substance in the eye. Initial signs of irritation were fully reversible over the 72 hour (7 day) observation period. The substance is considered not irritating to the eyes.
Reference
| Animal no | 1 | 2 | 3 | ||||||||||
| 1 | 24 | 48 | 72 | 7 | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | |
| cornea | D | 0 | 0 | 0 | 0 | D | 0 | 0 | 0 | D | 0 | 0 | 0 |
| iris | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| conjunctivae | |||||||||||||
| redness | 2 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 1 | 0 |
| chemosis | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
D= dulling of the cornea
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 information available the substance does not need to be classified for irritation according to 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.
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