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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD Guideline or GLP defined. No test material concentration and dose defined.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Principles of method if other than guideline:
A modification of the Maguire method was adopted. The method derives from the "Split-adjuvant" technique, in which chemical allergen and Freund´s adjuvant are administered separately to the skin rather than as an emulsion.
GLP compliance:
not specified
Type of study:
other: Maguire method
Justification for non-LLNA method:
The test was performed before the LLNA method was validated.

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic acid
EC Number:
201-873-2
EC Name:
Phthalic acid
Cas Number:
88-99-3
Molecular formula:
C8H6O4
IUPAC Name:
benzene-1,2-dicarboxylic acid
Details on test material:
1,2-Benzene-dicarboxylic acid
Specific details on test material used for the study:
substance is called 1,2-benzene-dicarboxylic acid (compound No. 23)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous, no further data given
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
other: epicutaneous, no further data given
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
10
Details on study design:
Prior to conducting the sensitization test, the test material was applied as recieved on the clipped flanks of guinea pigs 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 caus primary irritation was used for the test.

The test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs would be considered sufficient to classify the test material as a potential human skin sensitizer.
Positive control substance(s):
yes
Remarks:
Epichlorohydrin and diglycidyl ether of 2,2-di-(p,p'-hydroxyphenyl)propane

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
no data
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: no data. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Group:
positive control
Remarks on result:
other: diglycidiylether of 2,2-di-(p,p'-hydroxyphenyl)propane
Group:
negative control
Remarks on result:
other: Various chemical groups were evaluated for their skin sensitisation potential in guinea pigs. Therefore a sufficient basis for a negative control is available.

Any other information on results incl. tables

0 of 10 tested animals showed effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a modiefied method of the Maguire method the test procedure consisted of topical application of a 0.1 ml aliquot of the test material to the clipped and depilated backs of 10 Hartley guinea pigs for four times in 10 days. At the time of the third application, 0.2 ml of Freund´s adjuvant was injected intradermally at one point adjacent to the insult site. After a 2-week rest period, the guinea pigs were challenged on the clipped flanks with the test material on one flank and a solvent on the other flank. The challenge site was evaluated for erythema and edema at 24 and 48 hours. A moderate erythema and/or edema in two or more guinea pigs was considered sufficient to classify the test material as a potential human skin sensitizer. In 0/10 animals effects were observed, therefore the test substance was not found to be sensitising.