Registration Dossier
Registration Dossier
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EC number: 618-347-7 | CAS number: 9003-01-4
Skin sensitisation
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:
- 1 981
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:
- Study performed well before LLNA became the recommended test method.
Test material
- Reference substance name:
- Acrylic acid
- EC Number:
- 201-177-9
- EC Name:
- Acrylic acid
- Cas Number:
- 79-10-7
- Molecular formula:
- C3H4O2
- IUPAC Name:
- acrylic acid
- Details on test material:
- - Name of test material (as cited in study report): Acrylic acid
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- Induction: 0.1 ml aliquot of the test substance
Challenge: not specified
Challengeopen allclose all
- 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 chemical
- 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:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this modified Split Adjuvant Test in Guinea pigs, acrylic acid did not induce skin reactions indicative of sensitization.
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