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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: observation time should be longer to evaluate reversibility

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Principles of method if other than guideline:
0.1 ml undiluted testsubstance was applied into the eye of rabbits, time of reading: 24, 48 and 72 hours.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
m-cresol
EC Number:
203-577-9
EC Name:
m-cresol
Cas Number:
108-39-4
Molecular formula:
C7H8O
IUPAC Name:
m-cresol
Details on test material:
IUCLID4 Test substance: other TS: m-cresol, M.P.: 11-12 C; B.P.: 202.8 C

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye served as control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: score cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 24 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
other: see time point: 48 hours
Irritation parameter:
other: mean score: cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 48 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
other: see time point: 72 hours
Irritation parameter:
other: mean score: cornea, iris, conjunctivae
Basis:
animal: mean score of all animals
Time point:
other: 72 hours
Score:
ca. 87.3
Max. score:
110
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for edema score avaiable. Total irritation score: 87.3/110
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for iris score avaiable. Total irritation score: 91.3/110
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for conjunctivae score avaiable. Total irritation score: 91.3/110
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: no data for chemosis score avaiable. Total irritation score: 91.3/110
Irritant / corrosive response data:
From beginning of the observation all animals showed irritational effects in the cornea (score 60), iris (score 10) and concunctivae (score 16-18) of the eye which did not change during the observation period of 72 hours.
Other effects:
no data

Any other information on results incl. tables

after 24 hrs: cornea, iris, conjunctivae: 87.3 (mean score): -- mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
after 48 hrs: cornea, iris, conjunctivae: 87.3 (mean score):
-- mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
after 72 hrs: cornea, iris, conjunctivae: 87.3 (mean score)
--mean score for cornea: 60, mean score for iris: 10, mean score for conjunctivae: 18)
summary: irritation score: 87.3/110

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

Application of 0.1 ml into the eye of rabbits and observation up to 72 hours post application resulted in mean irritation score 87.3 of max 110. Reversibility was not reported.