Registration Dossier
Registration Dossier
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EC number: 206-330-3 | CAS number: 328-50-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-01-24 to1984-02-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-oxoglutaric acid
- EC Number:
- 206-330-3
- EC Name:
- 2-oxoglutaric acid
- Cas Number:
- 328-50-7
- Molecular formula:
- C5H6O5
- IUPAC Name:
- 2-oxopentanedioic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.8-2.5 kg
- Housing: singly in stainless steel cages model: Asta
- Diet (e.g. ad libitum): ad libitum, standard chow: ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 1°C
- Humidity (%): 50-60 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left side intact, untreated areas
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test item moistened with water - Duration of treatment / exposure:
- 4 hour exposure
- Observation period:
- up to 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²/animal
- Type of wrap if used: Areas were covered by linen patches which were fixed with Acylastic, P.Beiersdorf und Co. AG, Hamburg
- Differences to guideline: Abraded and intact skin was treated and observed, but only intact skin was used for evaluation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM:
- Method of calculation: Scoring according to the method of Draize et al., 1944
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: effects on intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: #2,#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: effects on intact skin
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal on intact skin at each observation time up to removal of each animal from the test
Score at time point/ Reversibility |
Erythema |
Edema |
|
Max. score: 4 |
Max. score: 2 |
24 h |
3/0/0 |
1/0/0 |
48 h |
2/1/1 |
1/0/0 |
72 h |
1/1/1 |
0/0/0 |
Average 24 h, 48 h, 72 h |
2/0.67/0.67 |
0.67/0/0 |
Reversibility *) |
c. |
c. |
Average time (unit) for reversion |
6 days |
6 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present conditions, occlusive application of the test item for 4 hours to intact and abraded rabbit skin revealed moderate irritating effects (moderate erythrema and slight edema) only in one out of three animals. The other two animals showed no reaction or exhibited a slightly irritating effect, respectively. However, these effects were fully reversible after maximum 6 days. Therefore the test item is not classified according to GHS citeria.
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