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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, short documentation, 24 h exposure time, purity not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: [application time: 24 h (OECD TG 404: 4 h); 6 animals have been used (OECD: 3); observation period 8 days (OECD: 14 d); occlusive testing (OECD: semiocclusive); additionally scarified skin was tested (OECD: no abraded skin test required)]
Principles of method if other than guideline:
Method: §1500.41; Federal Register Vol. 38, No. 187, pp 26019 dated 27.09.1973
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Chemical structure
Reference substance name:
Adipic acid
EC Number:
204-673-3
EC Name:
Adipic acid
Cas Number:
124-04-9
Molecular formula:
C6H10O4
IUPAC Name:
Hexanedioic acid
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): adipic acid
- Purity: 99.8%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 3.1 kg (2.45 kg - 3.43 kg)
- Diet: Ssniff K, standard diet, Intermast, Soest, Germany, ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped skin as well as clipped and scarified skin on the same animal
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of a 50% aqueous solution
Duration of treatment / exposure:
24 hour(s)
Observation period:
24h, 3 and 8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: The cloth on which the test substance was applied was covered with a gummed linnen cloth, which was fixed by sticking plasters and wrapped by a gauze bandage.

REMOVAL OF THE TEST SUBSTANCE
- no whashing done

ADDITIONAL INFORMATION
- During exposre animals were fixed and fasted.

SCORING SYSTEM:
- Draize Scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Skin irritation results on the intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Skin irritation results on the intact skin
Other effects:
- Four of the six test animals suffered from parasites in the liver

Any other information on results incl. tables

Reversible reddening was observed at the intact skin which
disappeared after three days. Mild to severe reddening and
edema was observed at the scarified skin. These effects were
reversible after 1 week and scale formation was observed.

Observation scores:

Intact skin:

Reddening:
time        score animal 1/2/3/4/5/6
24 h                     2/2/2/3/2/2
3 days                   0/0/0/0/0/0
8 days                   0/0/0/0/0/0
Oedema observation:
24 h                     0/0/0/0/0/0
3 days                   0/0/0/0/0/0
8 days                   0/0/0/0/0/0

Scarified skin

Reddening:
24 h                      2/3/3/3/2/2
3 days                    2/1/2/1/1/1
8 days                    0/0/0/0/0/0 scale formation in every case


Oedema observation:
24 h                       2/2/2/2/2/2
3 days                     2/0/2/0/1/0
8 days                     0/0/0/0/0/0

Applicant's summary and conclusion

Conclusions:
slightly irritating
Executive summary:

500 mg of a 50 % aqueous suspension of adipic acid (99.8 %) was tested on intact and scarified skin of six rabbits, respectively. The compound was applied to an area of 5 x 5 cm, covered and held in contact for 24 hours. Responses were scored immediately after dosing (24 hours), 3 and 8 days. Reversible reddening was observed at the intact skin (scored 2-3 on a scale up to a maximum of 4) which disappeared after three days. Mild to severe reddening and edema was observed at the scarified skin (scores 24 h: 2, 3 days: 0 - 2). These effects were reversible after 1 week (all scores 0) and scar formation was observed.