Registration Dossier
Registration Dossier
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EC number: 242-838-1 | CAS number: 19147-16-1
Skin irritation / corrosion
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:
- 1 978
- 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
- 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%
Constituent 1
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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Skin irritation results on the intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- 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.
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