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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
GPMT
Deviations:
yes
Remarks:
No positive control included
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
EC Number:
500-234-8
EC Name:
Alcohols, C12-14, ethoxylated, sulfates, sodium salts
Cas Number:
68891-38-3
Molecular formula:
not applicable, UVCB
IUPAC Name:
Alcohols, C12-14(even numbered), ethoxylated < 2.5 EO, sulfates, sodium salts

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
According to Guideline.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Intradermal induction: 0.05%
Day(s)/duration:
single applications
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Epicutaneous induction: 2.5 %
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Challenge: 0.1 and 0.5%
Adequacy of challenge:
not specified
No. of animals per dose:
20 (test group)
10 (control gro

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
1 animal with erythema: localized reaction, restricted to a small area of the challenge site.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
2 animals with erythema, 4 animals with erythema, localized reaction restricted to a small area of the challenge site.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
1 animal with erythema, localized reaction, restricted to a small area of the challenge site.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
5 animals with erythema, localized reaction, restricted to a small area of the challenge site.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
1 animal with erythema: localized reaction restricted to a small area of the challenge site.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
2 animals with erythema: localized reaction restricted to a small area of the challenge site.
Remarks on result:
other: anterior site
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animals with erythema: localized reaction restricted to a small area of the challenge site.
Remarks on result:
other: posterior site
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
2 animals with erythema: localised dermal reaction restricted to a small area of the challenge site.
Remarks on result:
other: anterior site
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animal with erythema: localised dermal reaction restricted to a small area of the challenge site.
Remarks on result:
other: posterior site
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0.5%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animal with erythema: localised dermal reaction restricted to a small area of the challenge site.
Remarks on result:
other: anterior site
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: posterior site
Group:
positive control
Remarks on result:
other: no information

Any other information on results incl. tables

 

Positive controls were not included.

Body weights were unaffected by treatment.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
In the present in vivo skin sensitisation guinea pig maximisation test, the test substance did not induce skin sensitising reactions in the tested animals. Local skin irritations were noted in a few cases, but the dermal reactions observed in the test animals were similar to those seen in animals of the control group. Therefore, it is concluded that in this test, the test substance did not produce any evidence of delayed contact hypersensitivity.