Chloroacetic acid

Eye irritation

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

Test material information

Constituent 1

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.