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EC number: 915-671-3 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-10-27 to 1989-11-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 Feb 1987
- Deviations:
- yes
- Remarks:
- 7 days observation period instead of 14 days
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Version: March 1984
- Deviations:
- yes
- Remarks:
- 7 day observation period instead of 14 days
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
- EC Number:
- 915-671-3
- Molecular formula:
- C17H22N2O4
- IUPAC Name:
- Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biological Research Laboratories Ltd., Fuellinsdorf, Switzerland
- Age at study initiation: 14 weeks (males) and 15 weeks (females)
- Weight at study initiation: 2.4 - 2.6 kg (males) and 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet: pelleted standard Kliba 341 rabbit maintainance diet (Kliba, Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: community tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 Oct 1989 To: 07 Nov 1989
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The test article was applied moistened with polyethylene glycol (PEG 400)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² shaved skin of the dorsal area
- Type of wrap if used: The test material was covered with a 3.0 cm x 3.0 cm patch of surgical gauze and covered with an semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the dressing the skin was rinsed with lukewarm water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS: 1, 24, 48 and 72 h and 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Slight (score 1, 1/3 rabbits) or well defined erythema (score 2, 2/3 rabbits) and very slight edema (score 1, 3/3 rabbits) was observed within 1 hour after removal of the patches. At the 24, 48 and 72 h reading time point, all animals had well defined erythema (score 2). Very slight edema (score 1) remained in all rabbits until 48 h after path removal. At study Day 7 there were no local signs of erythema and edema. However, slight scales were observed in 2/3 animals and moderate scales were observed in 1/3 animals on day 7 of observation.
- Other effects:
- Coloration:
In the area of application, brown staining of the treated skin by pigment or coloring of the test article was observed in all animals at each of the reading time points.
Body weights:
The body weight gain of all rabbits was similar.
Clinical symptoms / Mortality:
No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy:
No necropsy was performed. All animals were killed and discarded.
Any other information on results incl. tables
Table 1: Skin reactions and scores for the individual animals
| Sex | Erythema score | Edema score | ||||
| male | male | female | male | male | female | |
| Animal # | 63 | 64 | 65 | 63 | 64 | 65 |
| Reading time point | ||||||
| 1 h | 2 | 1 | 2 | 1 | 1 | 1 |
| 24 h | 2 | 2 | 2 | 1 | 1 | 1 |
| 48 h | 2 | 2 | 2 | 1 | 1 | 1 |
| 72 h | 2 | 2 | 2 | 0 | 0 | 0 |
| 7 days | 0 | 0 | 0 | 0 | 0 | 0 |
| 24/48/72 h mean | 2 | 2 | 2 | 0.67 | 0.67 | 0.67 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- All animals showed erythema and edema, which were fully reversible within 7 days. However, slight to moderate scales were observed in all three rabbits until the end of the 7 days observation period. Due to the shortened observation period of 7 instead of 14 days the reversibility of scales formation is unclear. Based on these findings and on a worst case approach, the substance is classified as Skin Irrit. 2 (H315) according to Regulation (EC) No. 1272/2008.
CLP: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008.
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