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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category section for information on the read-across approach.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Molecular formula:
Cannot be adequately determined for this UVCB substance
IUPAC Name:
Benzenesulfonic acid, mono and di-alkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% Concentration - Negative control
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% Concentration
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% concentration - Challenge phase
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: 2 of 20 animals gave positive indication of skin sensitization
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% Concentration - Challenge phase
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% in acetone
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% in acetone
No. with + reactions:
10
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following primary challenge of test substance at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced. Based on GHS guidelines < 15% of animals were sensitized to the material therefore, the Test substance is not classified for skin sensitization.
Executive summary:

The Test substance was tested for dermal sensitization potential using a 25% induction concentration. The Test substance was evaluated for sensitization potential by applying 0.4 ml at a 25% concentration directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6hour contact) of test substance at 10% concentration, on a naive site located on the

right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application. Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 10% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Following primary challenge of test substance, at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control

group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Based on GHS guidelines < 15% of animals were sensitized to the material, therefore, the Test substance is not classified for skin sensitization.