Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally acceptad scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
0.05 ml of the test substance was instillated in the eye.
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dimethyl sulfate
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult animals
- Weight at study initiation: 2.26 kg (female; 2.4 kg at the end of the study) and 2.35 kg (male; 2.4 kg at the end of the study)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
test substance was not washed out
Observation period (in vivo):
up to 8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was not washed out

SCORING SYSTEM:
Ocular reactions were recorded 10 min, 1, 3, 24, 48 hours, 5, 7, and 8 days after instillation using a BASF-scoring system, which is convertible into the current OECD Draize scheme.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
1.7
Max. score:
3
Reversibility:
other: corneal opacity, and strong chemosis with suppuration and staphyloma remained at the end of the observation period
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
The test substance is corrosive according to the EU and to GHS
Other effects:
After 1 hour eyes were totally swollen. After 24 hours very strong oedema, strong redness, iritis, bleeding and corneal opacity were reported. Even after 8 days strong redness, corneal opacity, and strong chemosis with suppuration and staphyloma remained.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information