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Registration Dossier
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EC number: 932-019-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 5, 1997 to July 3, 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,4,5,6-Tetrahydroxy-2-oxo-hexanoic acid
- IUPAC Name:
- 3,4,5,6-Tetrahydroxy-2-oxo-hexanoic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, KiBlegg
- Age at study initiation: about 14 weeks
- Weight at study initiation: 2.80-2.94 kg
- Housing: The rabbits were kept in an air conditioned room with separate cages (Becker, type K99/30 KU) with plastic grids on mobile racks.
- Diet (e.g. ad libitum): Altromin Standard Diet TPF 2113, pellets ad libitum
- Water (e.g. ad libitum): fresh tap water at least 3 times per week
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 59-70%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: To: June 5, 1997 to July 3, 1997
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test material was mixed with a few drops of Aqua pro injectione and spread into three patches. The patches were fastened to the left side of the animals backs and kept in place by a self-adhesive fabric.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The rabbits were examined after 1 hour, 24, 48, and 72 hours after the patches were removed, and then daily until day 8.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: Fixomull stretch, Beiersdorf
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72
- Score:
- 0.833
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0.165
- Irritant / corrosive response data:
- After an exposure period of four hours, erythema scores 1 and 2 were observed in two animals from day 1 through day 4. In one animal, edema score 1 was observed in the treated area during days 2 and three.
Any other information on results incl. tables
Animal |
2 |
4 |
6 |
Erythema |
|
|
|
1 hour |
2 |
0 |
1 |
24 hours |
2 |
0 |
1 |
48 hours |
2 |
0 |
1 |
72 hours |
1 |
0 |
0 |
Day 5 |
0 |
0 |
0 |
Day 6 |
0 |
0 |
0 |
Day 7 |
0 |
0 |
0 |
Day 8 |
0 |
0 |
0 |
Edema |
|
|
|
1 hour |
0 |
0 |
0 |
24 hours |
1 |
0 |
0 |
48 hours |
1 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Day 5 |
0 |
0 |
0 |
Day 6 |
0 |
0 |
0 |
Day 7 |
0 |
0 |
0 |
Day 8 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean etythema and edema scores were below 1 and therefore the substance is not classified as a skin irritant according to EU GHS guidelines.
- Executive summary:
This study examined the potential of the test substance to cause irritation to skin. The test substance was placed on the skin of 3 female rabbits for 4 hrs, and covered with a semi-occlusive patch. After 4 hrs, the test substance was removed with warm water. The animals were scored for signs of edema and erythema according to the Draize scale at 1, 24, 48, and 72 hrs and carried out through day 8 to ensure reversibility. A very slight sign of erythema was seen at hour 1, while signs of edema were seen at the 2 hr observation. The primary irritation index was 1.5, based on the cumulative mean scores of edema and erythema and all symptoms were fully reversible. The test substance is therefore not classified as a skin irritant according to EU GHS guidelines.
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