Registration Dossier
Registration Dossier
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EC number: 235-920-3 | CAS number: 13047-13-7
Endpoint summary
Administrative data
Description of key information
Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant to the skin (NOTOX 1985).
Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes (NOTOX 1985).
In an abstract of a study submitted to US-EPA, the substance was reported to be severly eye damaging (Kodak 1992)
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- last observation at 66 hours after removal of the patch instead of at 72 hours
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2810 - 3150 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: not defined
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 55-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: skin moistened with 0.5 mL water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL: 0.5 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 66 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: metaline mounted on permeable tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a water moistened tissue
- Time after start of exposure: at 4 hours
OBSERVATION TIME POINTS: 1, 24, 48 and 66 hours after removal of the dressing
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other:
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- no irritant effects at any of the observations (score 0)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-irrtant to the skin
- Executive summary:
Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant to the skin.
Reference
Animal no |
1 |
2 |
3 |
|||||||||
1 |
24 |
48 |
66 |
1 |
24 |
48 |
66 |
1 |
24 |
48 |
66 |
|
erythema |
0 |
0 |
0 |
0 |
0 |
0 |
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:
- 25 March 1985 to 11 June 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: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2761 - 3000 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 50-80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- grounded before instillation
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64 mg (0.1 mL)
VEHICLE: none
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and 7 and 14 days after instillation
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: at 24 and 48 h fluorescein staining was used - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: superficial epithelial corrosion of the cornea (10-20%) at 24 h after fluorescein treatment
- Remarks:
- no corneal damage at 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered non-irritant to the eyes
- Executive summary:
Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes.
Reference
Animal no |
1 |
2 |
3 |
|||||||||||||||
1 |
24 |
48 |
72 |
7 |
14 |
1 |
24 |
48 |
72 |
7 |
14 |
1 |
24 |
48 |
72 |
7 |
14 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
1 |
2 |
2 |
1 |
0 |
1 |
2 |
1 |
1 |
1 |
0 |
1 |
2 |
2 |
1 |
1 |
0 |
chemosis |
3 |
2 |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
1 |
0 |
0 |
3 |
2 |
1 |
1 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
The substance does not need to be classified for skin irritation and eye irritation according to EC 1272/2008 (CLP)
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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