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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-02-21 to 1989-03-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dodecanedioic acid of Hüls AG, purity ca. 99 %; impurities: homologous dicarboxylic acids, total 1 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation:  total mean 113 g
- Controls: no

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
ADMINISTRATION: 
- Preparation of test substance: grinding in mortar, suspension in corn  oil (30 %) with ultra turrax
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 10 ml/kg bw
- Post dose observation period: 14 days
Doses:
3000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days after treatment
- Clinical signs and mortality: within 6 hours after treatment,  thereafter daily
- Necropsy: all animals (macroscopic)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
MORTALITY: No deaths occurred
Clinical signs:
CLINICAL SIGNS: 
- 30 minutes after treatment: piloerection and slight sedation in all  animals
- 2 hours after treatment: no more sedation
- 3 hours after treatment: no more signs of toxicity
Body weight:
Body weight gain was not affected.
Gross pathology:
NECROPSY FINDINGS: No evidence of macroscopically discernible organ changes was found.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Executive summary:

In a acute oral limit test according to TG OECD 401 five rat per sex received a dose of 3000 mg/kg bw. There were no mortalities and no adverse effects other than initial slight sedation and piloerection which subsided after two hours.