Registration Dossier
Registration Dossier
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EC number: 931-714-9 | CAS number: 35255-57-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-03-25 to 1996-04-11
- 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 401 (Acute Oral Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- 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: 129 - 160 g, female: 126 - 137
- Fasting period before study: 16 hours
- Housing: max 5 animals per sex per cage
- Diet (e.g. ad libitum): Ssniff R 10, complete feed for rats, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- 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 hour light/dark rhythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 2.110 ml/kg bw ml/kg bw
- 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 - Doses:
- Limit test: 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: days 0, 7, and 14
- Clinical signs and mortality: 1/2, 1, 2, 3, 4, 5, 6 hours after treatment, thereafter daily
- Necropsy: all animals (macroscopic)
- Post dose observation period: 14 days - 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 in 3 males and 4 females.
Other animals: - 2-4 hours after treatment: Abnormal gait, crouched posture, slight sedation and ataxia, piloerection, slight hypothermia (1 male, 1 female), bloody lacrimation (1 male). - 5 hours after treatment: No more symptoms - Body weight:
- Body weight gain was not affected.
- Gross pathology:
- No evidence of macroscopically discernible organ changes was 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 acute toxicity after oral application is greater than 2000 mg/kg bw.
- Executive summary:
The test item (2000 mg/kg bw) was given to rats by oral administration to obtain information on the toxicity, in particular lethality, of the test item.
The test item was administrated oral to 5 male and 5 female WISTAR rats.
No signs of toxicity were observed in 3 males and 4 females. 2 males and 1 female showed 2 -4 hours after treatment following symptoms: abnormal gait, crouched posture, slight sedation and ataxia, piloerection, slight hypothermia (1 male, 1 female), bloody lacrimation (1 male). 5 hours after treatment there were no more symptoms.
There was no influence on the increase in body weight.
Dissection at the end of the experiment revealed no evidence of macroscopically discernible organs.
Under the conditions of this study the acute toxicity after oral application is greater than 2000 mg/kg bw.
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