1,2,3-trichloropropane

Eye irritation

Administrative data

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:

other: - followed recognized toxicology testing procedures - GLP compliant - study results copied without further assessment from the SIDS dossier

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

secondary source

Title:

SIDS INITIAL ASSESSMENT REPORT For SIAM 18 - 1,2,3-Trichloropropane

Author:

OECD

Year:

2004

Bibliographic source:

Published OECD SIDS initial assessments of HPV chemicals: http://www.oecd.org/document/63/0,3343,en_2649_34379_1897983_1_1_1_1,00.html

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: consistent with NAS Publication 1138 dtd 1977); Draize scoring method

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-trichloropropane

EC Number:

202-486-1

EC Name:

1,2,3-trichloropropane

Cas Number:

96-18-4

Molecular formula:

C3H5Cl3

IUPAC Name:

1,2,3-trichloropropane

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported in SIDS dossier
- Weight at study initiation: 2 - 2.9 Kg
- Fasting period before study: not reported in SIDS dossier
- Housing: 1 per cage
- Diet (e.g. ad libitum): not reported in SIDS dossier
- Water (e.g. ad libitum): not reported in SIDS dossier
- Acclimation period: not reported in SIDS dossier


ENVIRONMENTAL CONDITIONS
- not reported in SIDS dossier

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted


VEHICLE
- no vehicle used

Duration of treatment / exposure:

unwashed eye: continuous
washed eyes: washed out after 30 s

Observation period (in vivo):

Treated eyes of all animals were evaluated for irritation at 1, 6, 24, 72 hours and at 7 and 14 days

Number of animals or in vitro replicates:

3 male and 3 female New Zealand White rabbits; another 3 male rabbits received the same treatment but the eyes were washed 30 seconds after instillation with tap water

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of 9 animals, with tap water
- Time after start of exposure: 30 s after start of exposure


SCORING SYSTEM:
Draize score system/eye irritation scoring by Kay and Calandra
Treated eyes of all animals were evaluated for irritation at 1, 6, 24, 72 hours and at 7 and 14 days.

TOOL USED TO ASSESS SCORE: Corneas were reexamined at the same time periods with 0.2% sodium fluorescein. Animals were housed individually

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not reported in detail in the SIDS report

Score:

20

Max. score:

110

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: animals without wash-out; maximal overall irritation scores for individual animals were not reported in the SIDS report

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not reported in detail in the SIDS report

Score:

16.3

Max. score:

110

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: animals without wash-out; maximal overall irritation scores for individual animals were not reported in the SIDS report

Irritant / corrosive response data:

Superficial corneal ulcerations were detected in 4/6 unwashed eyes by 1 hour and in 5/6 by 6 hours; it was also observed in 2/3 washed eyes at 24 hours. The corneal ulceration reversed within 72 hours. Iritis was observed in 5/6 unwashed (clear in 72 hours) and 1/3 washed (clear in 24 hours). Some conjunctival irritation remained in both groups for 7 days (1/6 and 1/3, respectively). A maximum score of 20/110 was reported for unwashed eyes, and 16.3/110 for washed eyes. Test material was considered moderately irritating.

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

The irritating effects of 1,2,3-trichloropropane to the rabbit eye was tested using a recognized scientific procedure and followed recognized GLP procedures. A maximum overall irritation score of 20/110 was reported for unwashed eyes, and 16.3/110 for washed eyes.
The test material was considered moderately irritating by the authors of the study.

Executive summary:

In the present study (Shell Development Company, 1980d) male and female New Zealand White rabbits got 0.1 mL undiluted 1,2,3 -trichloropropane instilled into one eye and were analysed for eye irritation effects, body weight development and clinical signs for 14 d following generally the OECD TG 405 in compliance with GLP.

A maximum overall irritation score of 20/110 was reported for unwashed eyes, and 16.3/110 for washed eyes. The test material was considered moderately irritating by the authors of the study.

As no detailed individual data is available from the SIDS dossier in a conservative approach 1,2,3 -trichloropropane is classified as Category 2 ( Causes serious eye irritationr) regarding eye irritation according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

Nine rabbits, 3 males and 3 females in the unwashed group; 3 males in the washed group were tested. Test material (0.1 ml) was placed into the everted lower eye lid of 3 male and 3 female New Zealand White rabbits; another 3 male rabbits received the same treatment but the eyes were washed 30 seconds after instillation with tap water. Treated eyes of all animals were evaluated for irritation at 1, 6, 24, 72 hours and at 7 and 14 days. Corneas were reexamined at the same time periods with 0.2% sodium fluorescein. Animals were housed individually.

Superficial corneal ulcerations were detected in 4/6 unwashed eyes by 1 hour and in 5/6 by 6 hours; it was also observed in 2/3 washed eyes at 24 hours. The corneal ulceration reversed within 72 hours. Iritis was observed in 5/6 unwashed (clear in 72 hours) and 1/3 washed (clear in 24 hours). Some conjunctival irritation remained in both groups for 7 days (1/6 and 1/3, respectively). A maximum score of 20/110 was reported for unwashed eyes, and 16.3/110 for washed eyes. Test material was considered moderately irritating by the authors of the study..