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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Stevens MA. Use of the Albino Guinea-pig to Detect the Skin-sensitizing Ability of Chemicals. British journal of industrial medicine 1967;24(3):189-202
Principles of method if other than guideline:
In a routine test for skin-sensitizing potential, the test substance was applied over three days to the ears of guinea-pigs, and the flanks have been challenged one week later with a range of concentrations of suspected sensitizing substance. The erythematous reaction produced 24 hours after challenge was rated and compared with that in unsensitized controls.
GLP compliance:
no
Remarks:
Study pre-dates GLP
Type of study:
other: ear/flank test
Justification for non-LLNA method:
Study available is over 12 years old.

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
EC Number:
274-828-8
EC Name:
Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
Cas Number:
70729-65-6
Molecular formula:
C22H24N6O9
IUPAC Name:
methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate
Test material form:
liquid
Details on test material:
Disperse Red 311

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: AlderleyPark strain albino guinea pigs
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
N,N-dimethylformamide
Concentration / amount:
0.1 ml of a 10% w/v solution
Day(s)/duration:
3 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
N,N-dimethylformamide
Concentration / amount:
0.2 ml
5% w/v, 0.1% w/v and 0.01% w/v
Day(s)/duration:
1 day
No. of animals per dose:
6 animals
Details on study design:
The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of each ear of 6 guinea pigs (animal numbers 1 - 6) for three days
(days 1, 2 and 3). On Day 8, 0.2 ml of the challenge solutions (5% w/v, 0.1% w/v and 0.01% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank. The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
The erythema produced on each site was assessed 24 hours later (Day 9) and graded on a 6 point scale.
Challenge controls:
The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% w/v
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01% w/v
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% w/v
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1% w/v
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.01% w/v
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Induction was carried out using a 10.0% w/v solution of the test substance in dimethylformamide (DMF). The subsequent challenge was accomplished using 5.0, 0.1 and 0.01% w/v solutions in DMF.

None of the animals showed a visible erythemic response or any signs of oedema.

Applicant's summary and conclusion

Interpretation of results:
other: no skin sensitising effects noted
Conclusions:
No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.
Executive summary:

A study was carried out to determine the skin-sensitising potential of test article in the albino guinea pig. The study was performed in accordance with the ear/flank test method (Stevens).

 

The test article (0.1 ml of a 10% w/v solution in dimethylformamjde) was applied daily by means of a glass syringe to the outer surface of the ears of 6 guinea pigs (animal numbers 1 - 6) for three days (days 1, 2 and 3).

On Day 8, 0.2 ml of the challenge solutions (5% w/v, 0.1% w/v and 0.01% w/v in dimethylformamide) was applied topically to 1 cm diameter circular areas on the clipped flanks of each of the same 6 animals. Solutions of test article were also applied in the same way on Day 8 to the clipped flanks of control animals (animal numbers 7 - 10) which had no previous treatment on the ears. The applications were made on both flanks of all 10 guinea pigs, with each concentration being applied to each flank.

The highest concentration was applied closest to the posterior end of the animal while the lowest concentration was applied nearest the anterior end.

The erythema produced on each site was assessed 24 hours later (Day 9).

 

Results

No erythema was noted in any of the test or control animals. The test article was not considered to be a strong sensitiser.