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Toxicological information

Eye irritation

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980
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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: consistent with NAS Publication 1138 dtd 1977); Draize scoring method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,3-Trichloropropane
- Substance type: short-chain chlorinated hydrocarbon
- Physical state: clear colorless liquid
- Analytical purity: 98.25%
- Impurities (identity and concentrations): light ends of 0.66% and heavy ends 1.09%
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not reported in detail in the SIDS report
Score:
20
Max. score:
20
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
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not reported in detail in the SIDS report
Score:
16.3
Max. score:
16.3
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
Remarks:
Migrated information
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..