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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was tested for irritation in rabbit eye using the technique, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
EC Number:
245-442-7
EC Name:
N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]
Cas Number:
23128-74-7
Molecular formula:
C40H64N2O4
IUPAC Name:
N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]
Test material form:
not specified
Details on test material:
- Purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Obtained from suppliers in Switzerland
- Weight at study initiation: 2.2 to 2.7 kg
- Housing: Housed separately in wire cages (overall dimension 55 x 48 x 44 cm)
- Diet: NAFAG No. 84, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55-60
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye was left untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
24 h, 2, 3, and 4 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not washed

SCORING SYSTEM: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics of the AFDO

TOOL USED TO ASSESS SCORE: Slip lamp

- After application, the eyelids were held open for a few seconds

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating
Executive summary:

The test substance was tested for irritation in rabbit eye using the technique, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics of the US Association of Food and Drug Officials (AFDO). The test substance was tested on 6 rabbits of the New Zealand strain. 0.1 g of the test substance was introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The reactions were appraised with a slip lamp after 24 hours and after 2, 3, and 4 days. Under the present experimental conditions, no irritant effects were seen when the test substance was introduced into the rabbit eye.