Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 18 - June 7, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(March 22 1996)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of toxicolgy, BASF AG
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name as cited in report: Adipic acid, cyclic ester with diethyleneglycol
- Analytical purity: ca. 90%
- Physical state: Solid/white
- Storage: refrigerated
- Lot/batch No.: B 74

Test animals

Species:
rat
Strain:
other: Wistar (SPF)/CrI:WI (GLX/BRL/HAN) IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Deutschland, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: Male (approx. 8 - 12 weeks), Female (approx. 12 - 18 weeks)
- Weight range at study initiation: Male (162 - 173 g), Female (161 - 169 g)
- Fasting period before study: 16 h
- Housing: singly
- Diet: ad libitum, Kliba Labordiaet (the feed was assayed for chemical and microbiological contaminants)
- Water: ad libitum, tap water (drinking water is regularly assayed for chemical and microbiological contaminants)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

VEHICLE
- Justification for choice of vehicle: Aqueous formulation corresponded to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose:
Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2,000 mg/kg bw (limit test) was chosen in the first step with 3 female animals. As none of those animals died, 2,000 mg/kg bw were administered to 3 male animals in a second step. No mortalities were also observed. Because no mortality occurred, either study fulfilled the criteria for a limit test and was terminated.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs of toxicity and symptoms were recorded several times on the day of administration, at least once each workday for the individual animals. Individual body weights were taken shortly before application (day 0, before fasting period), after 1 week and at the end of the study. Mortality and moribund animals were checked for twice a day on work days, and once on Saturdays and Sundays and on public holidays
- Necropsy of survivors performed: yes
Gross-pathology examination were perfomed on the last day of the observation period. Withdrawal of food was performed at least 16 hours before killing with CO2.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured
Clinical signs:
No signs of toxicity were observed in males and female animals during the clinical examination.
Body weight:
Mean body weights increased for both genders through out the study period (see table below).
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (3 males and 3 females) examined at termination of the study.

Any other information on results incl. tables

Mean Body Weight:

Day 0

Day 7

Day 13

Male

169 g

205 g

221 g

Female

167 g

185 g

190 g

Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2,000 mg/kg body weight for male and female rats.

Applicant's summary and conclusion