1,3-diisopropylbenzene

Eye irritation

Administrative data

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

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:

The test was conducted according to an internal method. The following is mentioned: Test SOP No. TA 310, TA 160 and TA 120

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CRL (HA)BR Hartley
- Weight at study initiation:
Male: 390 - 483g,
Female: 282 - 349g

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

undilute as received

Duration of exposure:

2 weeks

Doses:

20 mL/kg

No. of animals per sex per dose:

five (5)

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Based on:

test mat.

Clinical signs:

other: no evidence of percutaneous absorption

Interpretation of results:

GHS criteria not met

Conclusions:

At most, test item is only slightly toxic by the dermal route. There was no evidence of percutaneous absorption. LD50 value was determined to be greater than 20 mL/kg bw (= ca. 20000 mg/kg bw/d).

Executive summary:

The acute toxicity to guinea pig in dermal test was performed. At most, test item is only slightly toxic by the dermal route. There was no evidence of percutaneous absorption. LD50 value was determined to be greater than 20mL/kg bw (= ca. 20000 mg/kg bw/d).

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

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:

The test was conducted according to an internal method. The test SOP NO. TA 300 and TA 120 are mentioned. The method of calculation was the Weil Method.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

TEST MATERIAL
- name as cited in test report: m-diisopropylbenzene
- Molecular weight: 162 g/mol
- Molecular formula: C12H18
- Physical state: liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability with H+; OH-; Heat, Light, H2: given

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: CRL: CD (SD) BR
- Weight at study initiation:
Male: 136 - 149g,
Female: 143 - 160g

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

undilute as received)

Details on oral exposure:

Test article was administered neat via oral gavage

Doses:

1250, 2500, 5000 mg/kg bw

No. of animals per sex per dose:

five (5)

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were reported for neither low, mid nor high dose group animals.

Gross pathology:

No compound-related effects were observed at gross pathology examination of the high-dose group of animals.

"At most, slightly toxic orally. No compound-related effects were observed at gross pathlogy examination of the high-dose group of animals."

LD50 (males) > 5000 mg/kg

LD50 (females) > 5000 mg/kg

Interpretation of results:

GHS criteria not met

Conclusions:

No compound-related effects were observed at gross pathology examination of the high-dose group of animals. The compound was considered to be slightly toxic following oral administration. The LD50 value was greater than 5000 mg/kg body weight.

Executive summary:

The acute toxicity to rats in oral gavage test was performed. No compound-related effects were observed at gross pathology examination of the high-dose group of animals. The compound was considered to be - at most - slightly toxic following oral administration. The LD50 value was greater than 5000 mg/kg body weight.

Cross-reference 3

Reason / purpose for cross-reference:

reference to same study

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.

Cross-reference 4

Reason / purpose for cross-reference:

reference to same study

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:

supporting 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 non-occlusive conditions for 9 consecutive days.

GLP compliance:

not specified

Species:

guinea pig

Strain:

Hartley

Remarks:

CRL: (HA)BR Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 349-425 g

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

9 daily doses

Observation period:

11 days

Number of animals:

five (5)

Details on study design:

no details given

Remarks on result:

probability of weak irritation

Remarks:

After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating.

Irritant / corrosive response data:

After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating.

Repeated application resulted in a slight exacerbation of the initial irritant response.

Skin Absorption: Not evident (Based on Dermal LD50 and Skin irritation studies)

Interpretation of results:

GHS criteria not met

Conclusions:

The test article, m-diisopropylbenzene, was determined to be slightly irritating

Executive summary:

In a skin irritation open repeat dose test a 0.5 mL aliquot of test substance (100 % test item) was applied topically to the shaved dorsal skin of guinea pigs each day for 9 consecutive days. After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating. As in this study the test item was applied on 9 consecutive days not just one time for 4 h as by the OECD Test Guideline 404, this is a clear worst-case result.

Cross-reference 5

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

only 10 animals tested, not many details provided in the report

Principles of method if other than guideline:

only 10 animals tested, not many details provided in the report

GLP compliance:

not specified

Type of study:

Buehler test

Justification for non-LLNA method:

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

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 324 - 415g

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

100% as received

Day(s)/duration:

3 weekly doses

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

100% as received

Day(s)/duration:

not specified

No. of animals per dose:

10

Details on study design:

no details given

Positive control substance(s):

no

Reading:

1st reading

Group:

negative control

Dose level:

0% v/v

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Hours after challenge is not indicated

Reading:

1st reading

Group:

test chemical

Dose level:

100% v/v

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Hours after challenge is not indicated . Doesn't show irritating sign

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

Preliminary tests had shown this material to be irritating to the abdomen, but not the backs of guinea pigs. During the course of the test, no irritation was observed during the induction phase using 100 % compound, so animals were challenged with the compound as received as well.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not sensitizing in guinea pigs

Executive summary:

A skin sensitisation test (Buehler method) was performed on guinea pigs. The test was done similar to OECD guideline 406. The sensitization potential of test item was assessed in guinea pigs using a Buehler test design. In the induction phase animals received 3 weekly applications of 100% of the test substance. Challenge was also performed with 100 % of the test substance. There were no signs of sensitization in any of the test animals. Consequently, the test substance was determined to be non-sensitizing in guinea pigs.

Cross-reference 6

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

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

Type of information:

experimental study

Adequacy of study:

supporting 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

GLP compliance:

not specified

Type of study:

other: Kodak method

Justification for non-LLNA method:

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

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 288 - 354g

Route:

epicutaneous, occlusive

Vehicle:

other:

Remarks:

0.05 mL of a 1 % solution in Freund's Complete Adjuvant

Concentration / amount:

1% v/v

Day(s)/duration:

not specified

Route:

intradermal

Vehicle:

other: 70% acetone + 20% dioxane + 10% guinea pig fat

Concentration / amount:

10% v/v

Day(s)/duration:

not specified

No. of animals per dose:

10

Details on study design:

The Kodak test involved induction by application of 0.05 mL of a 1% solution of m-diisopropylbenzene in Freund's Complete Adjuvant (FCA). Prior to application, the skin was also depilated prior to application to enhance contact and absorption. Subsequently, animals were challenged by subcutaneous injection of a 10% v/v solution of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat.

Challenge controls:

Guinea pigs that were treated during the induction phase with FCA without test substance

Positive control substance(s):

no

Reading:

other: Day 1-3

Group:

negative control

Dose level:

0% v/v

No. with + reactions:

0

Total no. in group:

10

Reading:

other: Day 1-3

Group:

test chemical

Dose level:

10% v/v

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Slight to moderate erythema and slight edema was observed

Reading:

other: Day 1-3

Group:

positive control

Remarks on result:

not measured/tested

Slight to moderate erythema and slight edema was observed on days 1 -3 following induction with test item.

Low potential fur human sensitization

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not sensitizing in guinea pigs

Executive summary:

The skin sensitisation Kodak method test was performed on guinea pigs. The dermal application of 0.05 mL of a 1% solution of test item in Freund's Complete Adjuvant (FCA) topically to guinea pigs produced slight to moderate erythema and slight edema for 1 -3 days. Animals were subsequently challenged by subcutaneous injection of a 10% v/v solution of the material into the foot pad of the test guinea pigs. There was no evidence of sensitization in any of the test guinea pigs. Consequently, m-diisopropylbenzene was determined to be non-sensitizing in guinea pigs.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

1,3-diisopropylbenzene

EC Number:

202-773-1

EC Name:

1,3-diisopropylbenzene

Cas Number:

99-62-7

Molecular formula:

C12H18

IUPAC Name:

1,3-bis(propan-2-yl)benzene

Test material form:

liquid

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

unwashed, washed

Time point:

other: 1 h

Score:

ca. 1

Max. score:

4

Reversibility:

not specified

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 13

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.

Applicant's summary and conclusion

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.