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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:
other: Acceptable, well-documented publication.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Principles of method if other than guideline:
Modified Maguire Method
GLP compliance:
no
Type of study:
split adjuvant test
Justification for non-LLNA method:
A reliable in vivo test was available before the implementation of the OECD 429 method.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Acrylic acid
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
Induction: 0.1 ml aliquot of the test substance
Challenge: not specified
Challenge
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
Induction: 0.1 ml aliquot of the test substance
Challenge: not specified
No. of animals per dose:
10
Details on study design:
- Positive control:
For induction, 10 guinea pigs were routinely subjected to the same dosing regimen with the diglycidyl ether of 2,2-di-(p,p'-hydroxyphenyl)propane (DER* 331 Epoxy Resin -- Dow Chemical U .S .A .), a known sensitizer to serve as a positive control . Challenge was performed two weeks after the lastinjection of the induction series.
Positive control substance(s):
yes
Remarks:
2,2-Di-(p,p'-hydroxyphenyl)propane didlycidyl ether (DER* 331 Epoxy Resin -- Dow Chemical U .S .A .)

Results and discussion

Positive control results:
The positive reference substance ( DER* 331 Epoxy Resin) induced moderate skin sensitization.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no data
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: no data. No with. + reactions: 7.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Preliminary study:

Prior to conducting the sensitization test, the test material was applied as received to the clipped flanks of animals to determine if primary irritation would occur. If significant irritation was observed, dilutions of the test material were made in a suitable solvent. The highest concentration which did not cause primary irritation was used for the sensitization test.

Test group:

Substance

animals tested

animals sensitized

Acrylic acid (0.1 ml aliquot)

10

0

Sensitization with the test substance was not observed in this test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met