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EC number: 931-714-9 | CAS number: 35255-57-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-03-11 to 1996-03-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- EC Number:
- 931-714-9
- Cas Number:
- 35255-57-3
- Molecular formula:
- C9H20O2
- IUPAC Name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: New Zealand white, HsdPoc:NZW
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Sex: female
- Weight at study initiation: 3.3; 3.6; 4.2 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Total volume applied: 0.5 ml undiluted test item
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 30-60 minutes, 24, 48, and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml test item
- Occlusion: gauze dressing fixed with non-irritant plaster, Acrylastic bandage
- Removal of test substance: washing with warm water
- Post exposure period: 3 days
EXAMINATIONS
- Examination time points: 30-60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: OECD Guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable
Any other information on results incl. tables
no other results
Applicant's summary and conclusion
- Conclusions:
- According to the study, the test item showed no irritant effect on the skin of female rabbits.
- Executive summary:
The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .
To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.
According to the study, the test item showed no irritant effect on the skin of female rabbits.
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