4-chloro-o-xylene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

According to OECD 405 guideline; under GLP conditions. Read-across to a structural analogue. The substance cited in section 1.1 (identification) and the structural analogue used in this study differ only in their regiochemistry. Both compounds possess similar chemical functional groups (aromatic carbon and aromatic carbon attached to chlorine) and are therefore expected to possess similar chemical reactivities. This study has been performed using 3-chloro-o-xylene as the test material but it is expected that the test substance will produce a similar result.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-2,3-dimethylbenzene

Cas Number:

608-23-1

Molecular formula:

C8H9Cl

IUPAC Name:

1-chloro-2,3-dimethylbenzene

Details on test material:

- Name of test material (as cited in study report): 3-chloro-o-xylene
- Molecular formula (if other than submission substance): C8H9Cl
- Molecular weight (if other than submission substance): 140.61
- Physical state: Liquid
- Storage condition of test material: Room temperature, dry place.
- Other: Stable under recommended conditions of storage and handling.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: at least 10 weeks
- Weight at study initiation: 2.06 - 2.13 kg
- Housing: Individually housed in suspended steel cages.
- Diet (e.g. ad libitum): TEK 8630 Rabbit diet, Harlan Teklad, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days under the same conditions as the test.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye of the test animal served as the control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24h

Observation period (in vivo):

1h, 24, 48h and 72h

Number of animals or in vitro replicates:

3 animals used in this study (2 male; 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were rinsed with USP 0.9% sodium chloride
- Time after start of exposure: 24h

SCORING SYSTEM: draize scoring system

TOOL USED TO ASSESS SCORE: hand-held slit lamp & fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

2

Max. score:

7

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

1

Max. score:

7

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48h

Score:

0.67

Max. score:

7

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

7

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1-72h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1-72h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

other: Fluorescein examination

Basis:

mean

Time point:

other: 24-72h

Score:

0

Max. score:

8

Irritant / corrosive response data:

- All 3 animals displayed mild conjunctival redness and chemosis at the 1h observation point. These findings were reversed at the 48h observation point in 1 animal and the 72h observation point in the other 2 animals.
- No fluorescein staining was evident in any of the test or control eyes of the animals at any observation point following exposure to the test material.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was evaluated for its potential to cause an irritating effect in the eyes of New Zealand White rabbits. Mild conjunctival redness and minor chemosis were observed at the 1h time point. All irritation and swelling resolved by the 72h observation point. Under the conditions of this study, the study author reports that the test material is considered to be a mild irritant to the eyes of New Zealand White rabbits, though this was not severe enough to warrant classification in accordance with EU criteria.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. The study was performed to GLP and the method was designed to meet the requirements of OECD Guidelines for the Testing of Chemicals No. 405 and EPA OPPTS 870.2400 (Acute Eye Irritation). A volume of 0.1 ml of the test material was placed into the conjunctival sac of the left eye of 3 animals. The right eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

No corneal or iridial effects were noted during the study. Minor conjunctival redness and chemosis was noted for all animals one hour after treatment. At the 24h observation point, minor redness was observed and this persisted to the 48h observation in 2 animals. At the 72h observation point, redness and chemosis was not observed. The test material was considered by the report author as a mild irritant to the rabbit eye, though this was not severe enough to warrant classification in accordance with EU criteria.