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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given.

Data source

Reference
Reference Type:
publication
Title:
Toxicological studies on p-tertiary-butyltoluene.
Author:
Hine CH et al.
Year:
1954
Bibliographic source:
AMA Arch Ind Hyg Occup Med 9: 227-244.

Materials and methods

Principles of method if other than guideline:
Draize Test according to
- Draize JH et al (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J Pharm Exp Ther 82:377-390.
- Carpenter CP and Smyth HF Jr (1946). Chemical Burns of the Rabbit Cornea. Am J Ophth 29: 1363-1372.
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butyltoluene
EC Number:
202-675-9
EC Name:
4-tert-butyltoluene
Cas Number:
98-51-1
Molecular formula:
C11H16
IUPAC Name:
1-tert-butyl-4-methylbenzene
Details on test material:
- Name of test material (as cited in study report): p-tertiary-butyltoluene
- Physical state: liquid with distinct odour
- Analytical purity: no data
No further data

Test animals / tissue source

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

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no details given
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no details given

VEHICLE : no data
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: 1 h
Score:
9.3
Remarks on result:
other: Draize method
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: 72 h
Score:
4
Remarks on result:
other: Draize method
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 h
Score:
6.6
Remarks on result:
other: Draize method
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: no data
Score:
< 1
Remarks on result:
other: method of Carpenter and Smyth
Irritant / corrosive response data:
The most consistent sign of eye irritation was a moderate to heavy discharge from the treated eyes. A slight chemosis was evident at the 24-hour point, but it had disappeared before the time of the 48-hour reading. According to Draize's method, the average total scores were 9.3 (1 h), 6.6 (24 h), and 4.0 (72 h) (maximum score = 110). According to the method of Carpenter and Smyth, the grade of irritation was less than 1.
According to the authors, these classifications indicate only a moderate irritation of the conjunctivae.
No further data.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS