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Administrative data

Description of key information

skin irritation: irritating

eye irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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)
GLP compliance:
yes
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

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.
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.

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

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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)
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Thomae, Biberach/D
- Age at study initiation:4 months
- Weight at study initiation: approx. 2210 g
- Housing: single holding
- Diet (e.g. ad libitum): Ssniff rabbit diet K 4; Ssniff GmbH, Soest/D 8Ad libitum)
- Water (e.g. ad libitum): tao water (ad libitum)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25°C
- Humidity (%): 45-70%
- Air changes (per hr): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours (rinsed with warm water)
TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible

animal no.

hours after application

1

24

48

72

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

1253

0

0

1

1

2

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1254

0

0

1

1

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1255

0

0

1

1

3

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

A = effects on cornea (turbidity degree)

B = effects on iris (intensity)

C = erythema

D = edema

E = exsudation

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

The undiluted test substance was applied to the dorsal shaved skin of three rabbits (Kleinrussen, CHbb:HM) at a dose of 0.5 g per animal. The contact time under semi-occlusive conditions was four hours [Method. Off. J. Europ. Commun. L 251, 27, 106 -108 (1984) and OECD-Guidelines for Testing of Chemicals No. 404]. Slight up to moderate erythema and slight up to weak edema were observed 1 - 72 hours after exposure. These irritation effects persited in one animal up to 21 days. Bis(methylcyclohexyl) phthalate proved to be irritating to the skin according to the test conditions.

Eye:

The undiluted test substance was tested for acute eye irritation on three rabbits (Kleinrussen, Chbb:HM) according to OECD guideline 405. The single application dose amounted to 0.1 ml per conjunctival sac. The observed conjunctival reactions (erythema and edema) were only mild and disappeared completely within 48 hours. The treated eyes were without any lesions on their cornea, and no effects on the iris were observerd at any time during the test. In conclusion, the bis(methylcyclohexyl)phthalate was not irritating to the rabbit's eye under these conditions.

In a pretest for a HET-CAM assay, the test substance caused almost no changes in the chorioallantoic membrane of the 3 eggs. No main experiment was conducted, since the irritation potential was judged to be minimal.

Justification for classification or non-classification

Based on the results of the skin and eye irritation tests, bis(metylcyclohexyl)phthalate needs to be classified as skin irrritating cat. 2 (H315) according to Regulation (EC) No 1272/2008 (CLP).