Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 March 1999 - 27 April 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
yelowish slightly turbid liquid
Density: ca. 0.86 g/ml
Expiry date: 10/99

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
2000 mg/kg bw; 200 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 2 female animals 8preliminary study)
200 mg/kg bw: 2 femalee, 3 male rats
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: 2 animals
200 mg/kg bw: no mortality
Clinical signs:
no abnormal signs
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
An oral LD50 value of > 200 - < 2000 mg/kg bw was determined
Executive summary:

The acute oral toxicity of akyl chlorides, C12 -14, reaction products with diethylenetriamine was investigated in an OECD 423 study in Wistar rats. In a range finding study two female animals were found dead after 5.5 h after administration of a dose of 2000 mg/kg bw by gavage.

In the main study a dose of 200 mg/kg bw was administered by gavage to 3 females and 3 male animals. No mortalities, no abnormal clinical signs and no findings in gross pathology were detected in a 14 day post operation period.

An oral LD50 value between > 200 and <= 2000 mg/kg bw can therefore be concluded.