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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990
Reference Type:
publication
Title:
Acute Toxicologic Evaluation of N,N'-Bis(1,4-dimethylpentyl)-p-phenylene diamine
Author:
Bomhard, E. et al.
Year:
1996
Bibliographic source:
J. Am. Coll. Toxicol. 15 (Suppl. 1), p. S73

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period only 7 days because no eye irritating effects observed
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
EC Number:
221-375-9
EC Name:
N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
Cas Number:
3081-14-9
Molecular formula:
C20H36N2
IUPAC Name:
N1,N4-bis(5-methylhexan-2-yl)benzene-1,4-diamine
Details on test material:
Vulkanox 4030 purity: 93.9%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h, 48, h, 72 h, 7 d
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h, 7 d
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h, 7 d
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h, 7d
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h, 7 d
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
other: aqueous humour
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h, 7 d
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects

Any other information on results incl. tables

The authors concluded that the results indicate that the test substance may be regarded as not irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The eye irritating potential of the test substance 77PD was evaluated in a GLP and OECD Guideline study (TG 405) in three female New Zealand White rabbits (Bayer AG 1990). A dose of 100 µl of the test substance was instilled into the conjunctival sac of one eye of each of the three rabbits; the other eye remained untreated and served as control. Twenty four hours after instillation of the test substance each treated eye was rinsed with saline. The eyes were examined and the grade of ocular reaction was recorded at one hour, 24 hours, 48 hours, 72 hours and seven days after termination of treatment. The signs of cornea, iris, conjunctivae and discharge were recorded as described by DRAIZE and the aqueous humour (opacity) as described by MCDONALD and SHADDUCK; in addition any other serious lesions or toxic effects were recorded. The test substance 77PD was not irritating to the eye (irritation index 0.0).