Registration Dossier
Registration Dossier
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EC number: 248-765-1 | CAS number: 27987-25-3
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(methylcyclohexyl) phthalate
- EC Number:
- 248-765-1
- EC Name:
- Bis(methylcyclohexyl) phthalate
- Cas Number:
- 27987-25-3
- Molecular formula:
- C22H30O4
- IUPAC Name:
- bis(1-methylcyclohexyl) phthalate
- Test material form:
- liquid: viscous
- Details on test material:
- 1,2-benzenedicarbonic acid, bis-(methylcyclohexyl)-ester (CAS: 27987-25-3)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source:Thomae, Biberach/FRG
- Sex: male
- Age at study initiation (in days): 19 months
- Weight at study initiation: mean 2880 g
- Housing: single housing
- Diet (e.g. ad libitum): adl ibitum (Altromin-Haltungsdiaet 2023 Altromin GmbH, Lage/FRG.)
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25°C
- Humidity (%): 45-70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 d
- Number of animals:
- 3
- Details on study design:
- The undiluted test substance was applied with a 6 cm² gauze-patch in a dose of 0.5 g to the shaved skin area. The patch was covered with an adhesive air- and vaporpermeable patch. The patch was fixed by using a hypoallergenic adhesive gauze-bandage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Slight up to moderate erythema and slight up to weak edema were observed 1 -72 hours after exposlure. These irritation effects persited in one animal up to 21 days.
Any other information on results incl. tables
animal no. |
hours after exposure |
|||||||
1 |
24 |
48 |
72 |
|||||
e |
ö |
e |
ö |
e |
ö |
e |
ö |
|
1232 |
1 |
0 |
2 |
0 |
2 |
1 |
2 |
1 |
1233 |
1 |
0 |
2 |
1 |
3 |
1 |
3 |
2 |
1235 |
1 |
0 |
2 |
0 |
2 |
1 |
3 |
1 |
animal no. |
days after exposure |
||||
7 rev. |
14 rev. |
21 rev. |
e |
ö |
|
1232 |
ø |
+ |
+ |
|
|
1233 |
ø S |
+ |
+ |
|
|
1235 |
ø S |
ø |
ø |
2 |
1 |
e= erythema ø= irreversible S= eschar
ö= edema += reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance proved to be irritating on the skin according to the test conditions.
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