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:
supporting study
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Old study, not to GLP, but sufficiently similar to current guidelines

Data source

Reference
Reference Type:
publication
Title:
The Toxicity of Allylamines
Author:
Hine, CH et al
Year:
1960
Bibliographic source:
Archives of Environmental Health, Volume 1, Pages 343-352

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Number of animals not stated
GLP compliance:
no
Remarks:
Old study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Molecular weight: 57.09
Boiling point: 52.9 deg C
Melting point: -88.2 deg C
Flash point, tag open cup: -20 deg F
Specific Gravity, 20/4 C: 0.7627
Solubility in water, 20 deg C, %W: complete
pH of 0.1M aqueous solution: 11.2
ppm in 1 mg/mL: 429

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No further details stated

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.05 mL applied to centre of cornea
Duration of treatment / exposure:
No details available
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Not stated
Details on study design:
Eyes examined in strong diffuse light, both unstained and stained with fluorescein solution. To be evaluated using Draize scores

Results and discussion

In vivo

Results
Irritation parameter:
other: too irritating to score
Reversibility:
not specified
Remarks on result:
other: extremely irritant

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: authors opinion
Conclusions:
Allylamine is extremely irritant to the eye
Executive summary:

Allylamine is extremely irritant to the eye, and the reaction did not permit differential readings