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Toxicological information

Skin irritation / corrosion

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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:
1991
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

Constituent 1
Chemical structure
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)

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.