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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
/ Basic data given. Report was limited, study was not GLP conform and purity of test substance was not given.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
secondary source
Title:
Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
Author:
US-EPA (American Chemistry Council's Aliphatic Esters Panel)
Year:
2010
Bibliographic source:
High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 18 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
On the day of application all animals showed diarrhea. Over the course of the study numbers of animals with diarrhea declined (1 male and female on day 1, and two males each on day 2 to day 4). Thereafter, no diarrhea was observed until day 13 and day 14 when 1 male each showed diarrhea. Other symptoms were lethargy from day 0 to day 2 shown by 2 males and females each, 1 male and female each and 1 male, respectively. Additionally, on day 0 one male animal appeared flaccid. From day 2 to day 4 all animals had an oily body, on day 2 and day 3 one male showed ptosis and on day 12 and 13 one male animal had chromorhinorrhea and on day 14 two male animals.

Any other information on results incl. tables

Table 1: Overview of clinical symptoms observed in rats treated by single oral gavage with 15000 mg/kg bw of test item

number of rats with sign (male/female)

 day 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
diarrhea 5/5 1/1 2/0 2/0 2/0                 1/0 1/0
lethargy 2/2 1/1 1/0                        
flaccid 1/0                            
body oily     5/5 5/5 5/5                    
ptosis     1/0 1/0                      
chromorhinorrhea                         1/0 1/0 2/0

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified