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EC number: 931-714-9 | CAS number: 35255-57-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-15 to 1996-05-02
- 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Germany
- Strain: HsdCpb: WU (SPF)
- Sex. male and female
- Weight at study initiation: male: 251-274 g, female: 209-233 g
- Housing: single
- Diet (e.g. ad libitum): Ssniff R 10, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / light rhythm
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- ADMINISTRATION:
- Area covered: dorsolumbar region, approximately 10 % of the body surface
- Doses: single dose, 2.110 ml/kg bw
- Occlusion: gauze dressing fixed with Acrylastic bandage (semiocclusive)
- Removal of test substance: after 24 hours with corn oil (MEH 56) and cellulose
- At first test item were administrated to 2 male and 2 femal rats, there were no mortality after 24 hours, test item were administrated to 3 male and 3 female rats - Duration of exposure:
- 24 hours
- Doses:
- single dose: 2.110 ml/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Clinical signs, mortality: 1/2, 1, 2, 3, 4, 5, and 6 hours after treatment, once daily for next 2 weeks
- Dermal response: Daily after patch removal
- Body weights: days 0, 7, and 14
- Macroscopic examination: day 14 (all animals) - Statistics:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred.
- Clinical signs:
- No signs of toxicity were observed. No erythema or edema were observed from patch removal to end of study.
- Body weight:
- Body weight gain was not affected.
- Gross pathology:
- No macroscopic changes in organs, skin, or subcutaneous tissue were found.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the LD50 of the acute dermal toxicity on male and female rats is above 2000 mg/kg of body weight for the test item in rats.
- Executive summary:
The test item was applicated at the skin of the male and female rats in a dose of 2000 mg/kg body weight
to obtain information on the toxicity, in particular lethality, of the test item.The test item was administrated dermal to 5 male and 5 female WISTAR rats.
No mortalities were observed at this dose. No signs of toxicity were observed. No erythema or edema were observed from patch removal to end of study.
Body weight gain was not affected.
No macroscopic changes in organs, skin, or subcutaneous tissue were found.
Hence the LD50 of the acute dermal toxicity on male and female rats is above 2000 mg/kg of body weight for the test item in rats.
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