1,3-diisopropylbenzene

Endpoint summary

Description of key information

Skin irritation

Skin irritation, guinea pig, 24 h occlusive, slightly irritating

 

Eye irritation

Eye irritation, rabbit, 8 days, slight eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Remarks:

in vivo study that was performed prior to current requirement for in vitro alternative testing

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 JUL 1985 - 20 DEC 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 guinea pigs were exposed to the test item under occlusive conditions for 24 h.

GLP compliance:

not specified

Species:

guinea pig

Strain:

Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CRL (HA)BR Hartley
- Weight at study initiation: 435 - 502g

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

Undilute as received

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

2 weeks

Number of animals:

five (5)

Details on study design:

no details given

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Score:

ca. 3

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

erythema score

Basis:

animal: 1-5

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal: 1-5

Time point:

72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to m-diisopropylbenzene. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure.

animal no.	finding	skin (post-exposure)
		24-48 hrs	2 weeks
1	erythema	mod-severe	normal
	edema		normal
2	erythema	well-defined	normal
	edema	very slight	normal
3	erythema	mod-severe	normal
	edema	very slight	normal
4	erythema	mod-severe	normal
	edema	slight	normal
5	erythema	well-defined	normal
	edema	very slight	normal

Interpretation of results:

GHS criteria not met

Conclusions:

The test article was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.

Executive summary:

A skin irritation test in guinea pigs was performed. Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to the test item. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Remarks:

in vivo study that was performed prior to current requirement for in vitro alternative testing

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

in vivo study that was performed prior to current requirement for in vitro alternative testing

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

0.1 mL of undiluted material was applied to each of 2 eyes of 3 rabbits; material was immediately washed from one eye of each rabbit with distilled water.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: New Zealand White
- Weight at study initiation: not determined

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL of undiluted material was applied to each of 2 eyes of 3 rabbits; material was immediately washed from one eye of each rabbit with distilled water

Duration of treatment / exposure:

one single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: immediate washing was palliative

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

unwashed, washed

Time point:

other: 1 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritant / corrosive response data:

Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of m-diisopropylbenzene. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be a slight eye irritant, which does not meet the criteria for classification and labelling according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

Executive summary:

The eye irritation was tested in three rabbits. Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of test item. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant, which does not meet the criteria for classification and labelling according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion
A skin irritation test in guinea pigs was performed. Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to test item. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.

 

Eye irritation
Eye irritation was tested in three rabbits. Slight irritation was observed in the conjunctiva and nictitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of test item. After 24 hours, irritation was not observed in the conjunctiva and nictitating membrane but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.

Justification for classification or non-classification

In two independent studies, the test item produced slight, transient irritation when applied to the skin of guinea pigs, and therefore does not satisfy the criteria for classification as a dermal irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

 

When instilled into the eye, test item produced mild and transient irritation of the conjunctiva, but no evidence of corneal opacity in rabbits.  

Based upon these findings, test item does not satisfy the criteria for classification as an ocular irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).