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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:
supporting study
Study period:
From February 29 to April 12, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study conducted similarly to OECD Guideline 406 with deviations: less no. of animals used in treatment group; concentrations applied in induction phase caused mortalities and strong dermal reactions. Interpretaion of the results may have been false.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
less no. of animals used in treatment group; concentrations applied in induction phase caused mortalities and strong dermal reactions
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Arsenic acid
- Physical state: Light green liquid
- Analytical purity: 75%
- Lot/batch No.: 8619
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Range finding test: Topical induction exposure
- Experiment 1: 25, 50, 75 or 100% w/v
- Experiment 2: 0.1, 1, 10 and 25% w/v

Main test:
- Topical induction exposure: 25% w/v (first two doses) and 10% w/v (last dose)
- Topical challenge exposure: 1% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Range finding test: Topical induction exposure
- Experiment 1: 25, 50, 75 or 100% w/v
- Experiment 2: 0.1, 1, 10 and 25% w/v

Main test:
- Topical induction exposure: 25% w/v (first two doses) and 10% w/v (last dose)
- Topical challenge exposure: 1% w/v
No. of animals per dose:
- Range finding test: 4 males
- Main test: 10 males (test and untreated control group), 4 males (positive control group)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 or 10% w/v in deionised water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
2/10 animals died within 10 days; surviving animals appeared normal at study termination
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 or 10% w/v in deionised water . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2/10 animals died within 10 days; surviving animals appeared normal at study termination.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 or 10% w/v in deionised water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
2/10 animals died within 10 days; surviving animals appeared normal at study termination
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 or 10% w/v in deionised water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2/10 animals died within 10 days; surviving animals appeared normal at study termination.

Any other information on results incl. tables

- 2/10 animals died within 10 days; surviving animals appeared normal at study termination

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under these test conditions, arsenic acid is not classified according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) No. 1272/2008.
Executive summary:

In a Buehler closed patch study conducted similarly to OECD Guideline 406 and in compliance with GLP, a group of 10 male Dunkin-Hartley guinea pigs were topically induced with arsenic acid (0.4 mL) at a concentration of 25% w/v (first two doses) or 10% w/v in deionised water (last dose) via occlusive patch for 6 hours, followed by a rest period of 2 weeks and then with a challenge patch of 1% w/v. Ten naive animals were applied with a challenge patch in the same manner. Four animals in the positive control group were applied with three induction patches of 0.3% w/v 2,4-dinitrochlorobenzene (DNCB) in 80% ethanol/deionised water followed by a challenge patch of 0.1% w/v DNCB in acetone. The test concentrations for the main study were determined from the range-finding studies conducted at concentrations of 25, 50, 75 and 100% w/v (study 1) and 0.1, 1, 10 and 25% w/v in deionised water (study 2).

 

Topical induction indicated evidence of mild to strong dermal reactions. No skin reactions were noted at the challenge sites of the test or untreated control group animals at the 24 or 48-hour observations. Arsenic acid produced a 0% (0/20) sensitisation rate and was considered to be a nonsensitiser to guinea pig skin. Positive control exhibited evidence of sensitisation, thus confirming the susceptibility of this group of animals to dermal sensitisation.

 

Under these test conditions, arsenic acid is not classified according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) No. 1272/2008. However this study is not considered as acceptable as it does not satisfy the guideline requirement for a skin sensitisation study.