Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March - April 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 9 weeks
- Weight at study initiation: males = 224-250g ; females = 160 -197 g
- Fasting period before study: yes
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The preparation was made immediately prior to dosing.
The animals received the test article on a mg/kg bw base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was agin presented approximately one hour after dosing.
Volume d'application = 20 ml
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations : four times during test day 1, and daily during days 2-15
- Frequency of weighing: on day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality
Clinical signs:
No signes of symptoms observed
Body weight:
No change
Gross pathology:
No macroscopic organ changes were observed
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity of Decanemethylendimethacrylate in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg.
Executive summary:

The test article decanemethylendimethacrylate was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg.

No death, no clinical signs, no change of body weight and no macroscopic changes were observed.

Indeed, the acute oral toxicity of Decanemethylendimethacrylate in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg.