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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:
migrated 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:
other: see 'Remark'
Remarks:
Not conducted under GLP. The method used is equivalent to OECD 406, but with reduced animal numbers (10 test, 8 control). Test item is identified as Fenopon AC78; which is Sodium Cocoyl Isethionate. Read-across is based upon a commonality of functional groups, constituents, breakdown products and metabolic pathways. A detailed justification is appended in Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Reduced animal numbers (10 test, 8 control)
Principles of method if other than guideline:
The method is intended to follow closely that described by Magnusson and Kligman (1,2).
1. Magnusson, B. and Kligman, A.M. 1969. The Identification of Contact Allergens by "Animal Assay. The Guinea Pig Maximisation Test.
2. Magnusson, B. and Kligman, A.M. 1970. Allergic Contact Dermatitis in the Guinea Pig. Identification of Contact Allergens. Thomas, Springfield, Illinois.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method.

Test material

Constituent 1
Reference substance name:
61789-32-0
Cas Number:
61789-32-0
IUPAC Name:
61789-32-0
Constituent 2
Reference substance name:
Sodium Cocoyl Isethionate
IUPAC Name:
Sodium Cocoyl Isethionate
Constituent 3
Reference substance name:
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
EC Number:
263-052-5
EC Name:
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
IUPAC Name:
263-052-5
Details on test material:
Test material is Sodium Cocoyl Isethionate. Test sample number S10605.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SEAC
- Age at study initiation: no details
- Weight at study initiation: ~320g
- Housing: no details
- Diet (e.g. ad libitum): R12 pellets, hay, cabbage, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no details


ENVIRONMENTAL CONDITIONS
No details


IN-LIFE DATES: From: 1978-08-28 To: 1978-11-14

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Physiological saline (for intradermal induction) and 80% distilled water and 20% PEG (for epicutaneous induction & challenge).
Concentration / amount:
A - Intradermal induction - 0.15% test substance (with physiological saline as solvent) suitably non-irritant concentration for injection.
B - Epicutaneous induction - 2.0 % test substance (with 80% distilled water and 20% PEG 400 as solvent) suitably irritant concentration.
C - Epicutaneous challenge - 5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent) suitably non-irritant concentration.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Physiological saline (for intradermal induction) and 80% distilled water and 20% PEG (for epicutaneous induction & challenge).
Concentration / amount:
A - Intradermal induction - 0.15% test substance (with physiological saline as solvent) suitably non-irritant concentration for injection.
B - Epicutaneous induction - 2.0 % test substance (with 80% distilled water and 20% PEG 400 as solvent) suitably irritant concentration.
C - Epicutaneous challenge - 5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent) suitably non-irritant concentration.
No. of animals per dose:
10 Test animals (six females and 4 males)
4 Treated control animals (females) in Challenge 1 (only).
4 Untreated control animals (males) in all challenges.
Details on study design:
RANGE FINDING TESTS:
Intradermal injection: 4 previously untreated guinea pigs (males) weighing approximately 320g were each injected intradermally on the clipped flanks with 0.1 ml aliquots of a range of concentrations of test substance in a suitable solvent. 24 hours later the reactions are examined for size (2 largest diameters) erythema and oedema. The concentration which produces a definite irritation reaction (10 x 10 mm, pale pink, with or without oedema) is selected as the intradermal injection induction concentration.

Topical application (for neck induction and flank challenge): 8mm diameter filter paper (Whatman 3MM patches), in 11mm "Fintest" aluminium patch test cups (Epitest Ltd), are saturated with a range of concentrations of test substance in a suitable solvent and the cups applied to the shaved flanks of 4 previously untreated guinea pigs of the same sex and weighing approximately 450g. The patches are held in place by adhesive plaster (Poroplast) wound around the trunk. 24 hours later the patches are removed, the reaction sites being examined 24 and 48 hours subsequently. The reactions are scored for irritation on a scale from 0 to +++. The concentration giving definite irritation (~+/- ) is selected for shoulder induction. The highest non-irritant concentration is chosen for sensitization challenge.
Challenge controls:
At every challenge in the test, 4 previously untreated control animals (male and weighing approximately the same as the test animals) were treated the same as the test animals, but without any induction treatment.
For each animal, an 8 mm diameter filter paper patch in an 11 mm aluminium patch test cup soaked in the test solvent (distilled water and PEG 400) was applied to the shaved flank. The patch was held in place for 24 hours by adhesive plaster wound around the trunk. The treatment sites were examined for evidence of sensitization 24 and 48 hours after removal of the patches.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: 1st challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: 1st challenge
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: 2nd challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: 2nd challenge
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
3rd challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Remarks:
3rd challenge
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: 4th challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
No. with + reactions:
1
Total no. in group:
8
Clinical observations:
At this fourth challenge, two test animals died due to neck lesions from the induction procedure. The mortalities were not due to the topical challenge.
Remarks on result:
other: 4th challenge
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
Remarks on result:
other: Some reactions were seen in the control animals. Details are not available.
Remarks:
Challenge No. 1, 2, 3 & 4
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5.0% test substance (with 80% distilled water and 20% PEG 400 as solvent)
Remarks on result:
other: Some reactions were seen in the control animals. Details are not available.
Remarks:
Challenge No 1, 2, 3 & 4
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: Not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: Not specified

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
1 out of 8 guinea pigs sensitised after 4 challenges
The test item is not classified as a skin sensitiser based on the result of this study.
Executive summary:

The Guinea Pig Maximizatin Test (GPMT), performed according to the Magnusson and Kligman method, was used. The animals weighed approximately 320 grams. The GPMT method involves induction in Guinea pigs by intradermal injections of both test substance and Freunds complete adjuvant. The induction process is supplemented seven days later by test substance applied to the shoulder injection sites and occluded by patch. Fourteen days later the animals were challenged by occluded patch on one flank. In this particular study, three subsequent challenges were then performed.

Three additional challenges were performed after the initial challenge. After the first challenge, 1 of 10 animals had a faint/very faint reaction at 24 hours and 2 of 10 animals showed the same reaction at 48 hours. After the second challenge, 2 of 10 animals had a faint/very faint reaction at 24 hours and 1 of 10 possibly showed the same reaction at 48 hours. After the third challenge, no animals showed any reactions. After the fourth challenge, 1 of 8 animals had a faint/very faint reaction at 24 hours with a further 1 of 8 with possible reactions, and 1 of 8 animals showed the same reaction at 48 hours. At this fourth challenge, two test animals died due to neck lesions from the induction procedure. The mortalities were not due to the topical challenge. Interpretation of the results is difficult due to the number of faint/very faint erythema reactions observed following each challenge. Some reactions were also seen in the control animals. Comparing the reactions at 24 hours versus 48 hours and the reproducibility of responses at each challenge, there is some evidence that one (and perhaps two) of the animals may have been weakly sensitized. However, the amount of background irritation in control animals and the weak responses in the test animals point towards this study being inconclusive.