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Registration Dossier
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EC number: 205-117-2 | CAS number: 133-66-4
Endpoint summary
Administrative data
Description of key information
assessment used to read across:
Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- In deviation of modern guidelines occlusive patches were used in this study, representing exaggerated exposure conditions.
- Principles of method if other than guideline:
- The procedure used is based, but not in every part identical with the proposed guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study". Federal Register, Vol 43 No. 163, August 22, 1978.
- GLP compliance:
- not specified
- 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
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- adraded skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritant to skin.
Reference
Erythema score after 24, 48 and 72 h (animal1/2/3/4/5/6)
| Exposure time | 24 h | 48 h | 72 h | |
| intact skin | 2/2/2/2/1/1 | 2/2/2/2/1/1 | 1/2/1/1/0/0 | |
| abraded skin | 2/1/0/2/1/1 | 1/1/0/2/1/1 | 1/0/0/0/0/0 |
Edema score after 24, 48 and 72 h (animal1/2/3/4/5/6)
| Exposure time | 24 h | 48 h | 72 h | |
| intact skin | 1/2/1/0/0/0 | 1/1/1/0/0/0 | 0/1/0/0/0/0 | |
| abraded skin | 1/1/0/1/0/0 | 1/0/0/0/0/0 | 1/0/0/0/0/0 |
All effects were fully reversible within 7 days (all scores: 0.0). There was no staining of the treated skin.
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Principles of method if other than guideline:
- The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study".
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye was not treated and served as an untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single exposure; in 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was washed out
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of sterile physiological saline.
- Time after start of exposure: In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- rinsed and unrinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no reactions
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- rinsed and unrinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no reactions
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- rinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- rinsed eyes
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritant to eyes.
Reference
Findings animal 1/2/3 (undiluted test substance, eyes not washed out):
| Time | Opacity | Iritis | Erythema | Chemosis | ||||||||||
| 24 h | 0/0/0 | 0/0/0 | 0/1/1 | 1/0/0 | ||||||||||
| 48 h | 0/0/0 |
0/0/0 | 0/1/0 | 0/0/0 | ||||||||||
| 72 h | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | ||||||||||
| 7 d | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | ||||||||||
| Mean: 24h - 48h - 72h | 0/0/0 | 0/0/0 | 0/0.7/0.3 | 0.3/0/0 | ||||||||||
Findings animal 4/5/6 (undiluted test substance, eyes washed out):
| Time | Opacity | Iritis | Erythema | Chemosis | ||||||||||
| 24 h | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/1 | ||||||||||
| 48 h | 0/0/0 |
0/0/0 | 0/0/0 | 0/0/0 | ||||||||||
| 72 h | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | ||||||||||
| 7 d | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | ||||||||||
| Mean: 24h - 48h - 72h | 0/0/0 | 0/0/0 | 0.3/0/0 | 0/0/0.3 | ||||||||||
FAT 65'023/L was found to cause mild irritation when applied to the rabbit eye mucosa.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
In a primary dermal irritation study with a close structural analogue (CAS 16090 -02 -1), 6 New Zealand White rabbits were dermally exposed to 0.5 mL of test substance for 24 hours under occlusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 1.4 and for edema was 0.4. The skin reactions observed were fully reversible until the end of the observation period on day 7. In this study, the tested substance CAS 16090-02-1) is not a dermal irritant.
Due to the consistent observation that the substance does not induce skin irritation it is concluded that the substance CAS 133 -66 -4 is also not irritating to skin and has not to be classified as skin irritation.
Eye:
An eye irritation test was performed with three New Zealand White rabbits on a close structural analogue (CAS 16090 -02 -1). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for iritis and cornea opacity were 0 at any reading time point. For conjunctivae redness the mean score was 0.3 and for conjunctivae chemosis 0.1. The eye reactions observed were fully reversible within 72 and 48 hours, respectively. In this study the family member (CAS 16090-02-1) is not an eye irritant.
Due to the consistent observation that the substance does not induce eye irritation it is concluded that the substance CAS 133 -66 -4 is not irritating to eye and has not to be classified as eye irritant.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under 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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