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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older proprietary study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Section 1500.42 of the Federal Hazardous Substance Act
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Study design comparable to OECD 405
GLP compliance:
no
Remarks:
: study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details are reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand albino rabbits were subjected to one-tenth of a milliliter of test material into their conjunctival sac of one eye. The contralacteral eye served as a control.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as an internal control
Amount / concentration applied:
one-tenth of a milliliter of test material was injected into the conjunctival sac.
Duration of treatment / exposure:
Single instillation of 0.1 ml test substance; eyes were unwashed
Observation period (in vivo):
The ocular reactions were scored at 1, 24, 48 , 72 hours , 4 and 7 days after instillation
Number of animals or in vitro replicates:
Six New Zealand albino rabbits
Details on study design:
Six New Zealand albino rabbits were subjected to one-tenth of a milliliter of test material into their conjunctival sac of one eye. The contralacteral eye served as a control The ocular reactions were graded at 1, 24, 48 , 72 hours , 4 and 7 days after instillation in accordance with Section 1500.42 of the Federal Hazardous Substance Act.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
: not calculated due to the severity of effects
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
other: not investigated
Remarks on result:
other: Scoring could not be done due to the irreversible damage to the eye tissue on contact
Irritant / corrosive response data:
Scoring could not be done due to the irreversible damage to the eye tissue on contact
Other effects:
Severe effects were noted following application of the test material

Any other information on results incl. tables

Irreversible tissue destruction was seen in this study.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Scoring could not be done due to the irreversible damage to the eye tissue on contact. The test material is a severe eye irritant.
Executive summary:

Instillation of 0.1 ml of the test material caused immediate tissue destruction in the rabbit eye. The test material is a severe eye irritant.