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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 study: meets scientific standards with acceptable restrictions (e.g. partly limited documentation)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1976 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
Draize test: 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs.
GLP compliance:
no
Remarks:
Study from 1976 (GLP was not compulsory at the time the study was performed).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: XF 958

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
No further data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL of undiluted TS
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
168 hrs
Number of animals or in vitro replicates:
6
Details on study design:
No further data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
3.2
Max. score:
110
Reversibility:
fully reversible within: 72 hrs

Any other information on results incl. tables

Hours

1

24

48

72

120

168

Mean score (X/110)

10.3

6.6

3.0

0.0

0.0

0.0

Irritation score (24, 48, 72 hrs average): 3.2

Immediate: slight discomfort

10 min: slight to moderate erythema, copious discharge

1 h: slight to moderate erythema, very slight oedema, copious discharge

24 hrs: slight erythema, moderate to copious discharge

48 hrs: gradual improvement

72 hrs: all scored zero

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The TS was classified as slightly eye irritating.
Executive summary:

In this older study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs. The irritation score (24, 48, 72 hrs average) was given with 3.2 and the effects were fully reversible within 72 hrs. The TS was classified as slightly eye irritating.