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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
EC Number:
251-607-4
EC Name:
4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline
Cas Number:
33629-47-9
Molecular formula:
C14H21N3O4
IUPAC Name:
N-sec-butyl-4-tert-butyl-2,6-dinitroaniline
impurity 1
Chemical structure
Reference substance name:
Xylene
EC Number:
215-535-7
EC Name:
Xylene
Cas Number:
1330-20-7
Molecular formula:
C8H10
IUPAC Name:
m-xylene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Time point:
24 h
Score:
>= 0 - <= 2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The test article was intilled into the left eye of six albino rabbits. The eyes examined 1, 24, 48, 72 hours after treatment. Te test article produced irritation ranging from mild to moderate in the treated eye up to Day 2. However, complete reversibility was evident by Day 3. Under the conditions of the present study, the test article appears to possess minimal irritation potential.