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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
Study period:
6-22 March 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline: federal register 38, no. 187, 27-09-1973, p 27019
Deviations:
not specified
GLP compliance:
no
Remarks:
did not exist at that time

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroacetic acid
EC Number:
201-178-4
EC Name:
Chloroacetic acid
Cas Number:
79-11-8
Molecular formula:
C2H3ClO2
IUPAC Name:
chloroacetic acid
Details on test material:
Monochloroessigsaure VA 2308. No further details specified.
Specific details on test material used for the study:
crystalline flakes dissolved in physiological saline

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst Aktiengesellschaft (breeding at the same laboratory)
- Weight at study initiation: 1.5-2.5 kg
- Housing: single housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
no data

IN-LIFE DATES: From: 06-March 1979 To: 22-March 1979

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
100 mg pasted with 0.01 mL vehicle
Duration of treatment / exposure:
Single application in one eye; the other one functioned as control
Observation period (in vivo):
1, 7, 24, 48, and 72 h (however, due to welfare reasons animals were sacrificed at 24h)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with physiological saline.
- Time after start of exposure: 24h after treatment

SCORING SYSTEM: Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA, Austin , Texas, p. 51, 1975

The 48-h and 72-h observation was done after installation of a drop of Na-fluoroescien (0.01%).

Results and discussion

In vivo

Results
Irritation parameter:
other: Irritation index
Basis:
mean
Time point:
24 h
Score:
106
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: severe eye irration; animals were sacrificed after 24 h, no individual scores were given
Remarks:
In this older study other scoring criteria have been used
Irritant / corrosive response data:
Highest irritation index of 106 was observed at 7 and 24 h- mucous membrane was grey discoloured and corrosive.
Because of animal welfare reasons the study was terminated at 24 h.
Other effects:
Not reported

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Severely damaging to the eyes. Animals were sacrificed at 24 h due to welfare reasons.