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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, basic data given.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
The study was conducted according to the method described by Klecak (1977) and Klecak and Geleick (1977).
GLP compliance:
no
Type of study:
Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acrylic acid
- Analytical purity: 55% (gas chromatigraphy) / >98% after destillation procedure.
- Impurities (concentrations): 45% (gas chromatography) / < 2% after destillation procedure.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan white and Dunkin-Hartley (two strains due to the shortage of animals)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Himalayan white (Inst. for Biomedical Research, Füllinsdorf, Switzerland) / Dunkin-Hartley (Olac Ltd., Bicester, England)
- Weight at study initiation: 350-450 g
- Housing: in pairs
- Diet (ad libitum): Pellet
- Water (ad libitum): water containing vitamin C


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Refer to Details on study design (Traditional tests)
Concentration / amount:
Induction: 0.5 M
Challenge: no concentration given
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Refer to Details on study design (Traditional tests)
Concentration / amount:
Induction: 0.5 M
Challenge: no concentration given
No. of animals per dose:
8
Details on study design:
RANGE FINDING TESTS:
Skin irritation caused by a single open application was determined for Acrylic acid in FCA pretreated animals (not participating in the sensitization procedure). On the clipped flank of 8 animals 0.025 ml of the test substance was applied with a pipette in progressively diluted (one third) concentrations, each in areas of 2 cm2 marked with a circular stamp. A mixture of 2 parts methyl ethyl ketone and 1 part of peanut oil by volume (Aramek) was used as a solvent. The reactions were read after 24 and 48 h. The maximum nonirritating concentration (m.n.i.c.) was determined, which is the highest concentration not causing a macroscopic reaction in any of the animals.


MAIN STUDY
A. INDUCTION EXPOSURE
After the acid was emulsified in FCA, an equal volume of distilled water was added. On days 0, 2, 4, 7 and 9 intradermal injections with 0.1 ml of this emulsion were given in the shoulder area from the left to the right paw. Control animals were similarly treated with FCA, blended with an equal volume of distilled water.

B. CHALLENGE EXPOSURE
All the animals were tested epicutaneously on day 21 (right flank) and day 35 (left flank). On day 21 right flank and on day 35 left flank of both groups were shaved. The test substance and the vehicle was applied in an amount of 0.025 ml with a pipette on an area of 2 cm2, marked with a circular stamp. The test sites were left uncovered and read at 24 h and 48 h.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test group (Acrylic acid containing an unidentified impurity of 45%)
Dose level:
no data
No. with + reactions:
8
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test group (Acrylic acid (destillate, >98%)
Dose level:
no data
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing