Registration Dossier
Registration Dossier
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EC number: 605-659-3 | CAS number: 173046-61-2
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (BASF, 1994)
Eye irritation: irritating to eyes (BASF, 1994)
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1/92
- Physical State/appearance: liquid, slight yellowish - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.55 -2.90 kg
- Housing: single housing
- Diet (e.g. ad libitum):about 130 g per animal per day; Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): about 250 ml tap wter per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern and Fixomull Stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/Water (1:1)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1h, 24 h, 48 h, 72 h and 8 d - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions chosen and considering the described findings Laromer LR 8889 X does not give indication of an irritant property to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Regulation, Title 16, Section 1500.41
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 877-4453
- Appearance: liquid - 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: 10 - 11 weeks
- Weight at study initiation: 2.6 - 2.6 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum (standard laboratory diet SDS Stanrab (P) Rabbit Diet)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 3 days (all skin reactions had completely disappeared at this time point)
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Elastoplast elastic adhesive dressing backed with Sleek waterproof strapping
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warrm water (30 - 40°C); blotted dry with absorbent paper
- Time after start of exposure: 24 hours - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Very slight to weIl-defined erythema with or without very slight oedema was seen at two intact and six abraded sites at the 24 hour reading. By the 72 hour reading, dermal responses had resolved completely in all animals.
The Primary Irritation Index (PII) was calculated to be: 0.5 - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Readings |
Animal |
Erythema |
Edema |
1 h |
1 |
1 |
0 |
2 |
1 |
0 |
|
3 |
0 |
0 |
|
24 h |
1 |
1 |
0 |
2 |
1 |
0 |
|
3 |
0 |
0 |
|
48 h |
1 |
2 |
0 |
2 |
1 |
0 |
|
3 |
1 |
0 |
|
72 h |
1 |
2 |
0 |
2 |
1 |
0 |
|
3 |
1 |
0 |
|
8 d |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
Mean |
1 |
1.7 |
0.0 |
2 |
1.0 |
0.0 |
|
3 |
0.7 |
0.0 |
|
Mean |
|
1.1 |
0.0 |
Rabbit number and sex |
E = Erythema O = Oedema |
24 hours |
72 hours |
||
Intact |
Abraded |
Intact |
Abraded |
||
2399 (male) |
E |
2 |
2 |
0 |
0 |
O |
1 |
1 |
0 |
0 |
|
2417 (male) |
E |
1 |
1 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
|
2401 (male) |
E |
0 |
1 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
|
2402 (male) |
E |
0 |
1 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
|
2403 (male) |
E |
0 |
1 |
0 |
0 |
O |
0 |
1 |
0 |
0 |
|
2404 (male) |
E |
0 |
1 |
0 |
0 |
O |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1/92
- Physical state/appearance: liquid, slight yellowish - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.52 -3.81 kg
- Housing: single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap wter per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24 °C
- Humidity (%): 30 -70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: 1, 24, 48, 72 hours and 8 days
Single application to the conjunctival sac of the right eyelid; the substance was not washed out. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings Laromer LR 8889 X is mildly irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The potential of Laromer LR 8889 X to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 1.1 for erythema and 0.0 for Edema. The findings were reversible in all animals 8 days after application, thus the study was terminated. Under the test conditions chosen and considering the described findings Laromer LR 8889 X does not give indication of an irritant property to the skin (BASF, 1994).
In a second study according to Federal Regulations, Title 16, Section 1500.41, six rabbits were exposed to a dermal dose of 0.5 ml of the test substance for 24h under occlusive conditions to one intact and one abraded skin site and observed for three days. On the intact skin, very slight to slight erythema were observed in two of the six animals, which had completely disappeared on day 3. One animal showed a very slight oedema after 24h only. The remaining animals were free of any skin reactions on the intact skin. Even on the abraded skin, reactions were very mild and had all resolved after 72h. The Primary Irritation Index (PII) was calculated to be 0.5 (Huntingdon, 1997).
Eye irritation:
The potential of Laromer LR 8889 X to cause damage or irritation to the conjunctiva, iris or cornea was assessed in 3 White Vienna rabbits, subjected to a single ocular application of 0.1 ml of the test substance. The average score (24 to 72 hours) for irritation was calculated to be 0.9 for corneal opacity, 02. for iris, 1.8 for conjnctivae redness, and 0.9 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Under the test conditions chosen and considering the described findings Laromer LR 8889 X is mildly irritating to eyes (BASF, 1994).
Justification for classification or non-classification
Based on the results of the skin and eye irritating testing, the test item is classified as eye irritating cat. 2B (H319) according to Regulation (EC) No 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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