Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(dimethylamino)propan-2-ol
EC Number:
203-556-4
EC Name:
1-(dimethylamino)propan-2-ol
Cas Number:
108-16-7
Molecular formula:
C5H13NO
IUPAC Name:
1-(dimethylamino)propan-2-ol
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethyl-isopropanolamin
- Physical state: liquid
no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean ca. 2.38 kg


ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 1 drop of 85% NaCl solution in the left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
similar to the one described in OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: staphyloma formation and severe necrosis
Irritation parameter:
conjunctivae score
Basis:
other:
Time point:
other: 1 h - 24 h
Remarks on result:
other: further scoring not possible due to brownish crustation
Irritant / corrosive response data:
Application of the test substance led to severe chemical burns on the eye. Corneal opacity grade 3-4 was observed throughout the study and was not reversible within 8 days.

Applicant's summary and conclusion

Interpretation of results:
corrosive