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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Reproduced from SIAR 6-tert-Butyl-m-cresol, 08.08.2002 from HPV/ICCA; peer reviewed report, secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
No information
Author:
Sumitomo Chemical (1988b)
Year:
1988
Bibliographic source:
cited: OECD SIDS Initial Assessment Report, Boston 20-25th Oct. 2002

Materials and methods

Principles of method if other than guideline:
Method: other: Draize's (scoring) and Kay & Calandra's (classification) method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Produced by Sumitomo Chemical, Lot No. 80159.Purity 98.5%.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml/eye
Duration of treatment / exposure:
unwashed eye: 24 h data available
unwashed eye: duration of application not mentioned
Observation period (in vivo):
unknown, 24 h values available
Number of animals or in vitro replicates:
3
Details on study design:
no further data

Results and discussion

In vivo

Other effects:
no data

Any other information on results incl. tables

Extreme irritating was observed at 24 hr (MMTS: 58.3) after 0.1 ml/eye  
application(unwashed). In the washed group, irritating potency was judged  
to be moderate at 24 hr ( MMTS: 36.3 ).

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

method: Draize's (scoring) and Kay & Calandra's (classification) method

result: highly irritating (risk of serious damage to eyes)

reference: Sumitomo (1988)