Registration Dossier

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:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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.