Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)

Data source

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

Materials and methods

Principles of method if other than guideline:
see attached report
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid undiluted
Details on test material:
- Name of test material (as cited in study report): 2,6-Dimethylphenoxyaceton

Test animals

Species:
rat
Strain:
other: Chbb:THOM
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. K. Thomae, Biberach/Riß
- Age at study initiation: 56 - 57 days
- Weight at study initiation: male ca. 235.0 g ; female ca. 168.8 g
- Fasting period before study: 16 - 20 hours before application
- Housing: : Animals were housed individually in Makrolon cages type III
- Diet (e.g. ad libitum): ad libitum Altromin R 8013
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 50 - 65
- Photoperiod (hrs dark / hrs light ) : 12 : 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1.6, 2.5 and 4.0 mL/kg corresponds to:
1648, 2575 and 4120 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : clinical signs - permanent during Day 1 , than once or twice a day until Day 14
body weight - Day before application , Day 8 + 15
- Necropsy of survivors performed: yes
Statistics:
Males:Probitanalyse
Females: logarithmic transformation of Dose-Values according Kärber-Procedure

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 880 - 3 090 mg/kg bw
Based on:
test mat.
Mortality:
Male, 2575 mg/kg , Number of animals : 5 ; Number of deaths : 3
Male, 4120 mg/kg , Number of animals : 5 ; Number of deaths : 3

Female, 2575 mg/kg , Number of animals : 5 ; Number of deaths : 2
Female, 4120 mg/kg , Number of animals : 5 ; Number of deaths : 5

12 animals died within 24 hours after application, 1 animal died on Day 2 after application
Clinical signs:
face-down and lateral position, reduced motility, gasping, tachypnoe, vocalization, lacrimation, ataxia, salvia, coma, ( see full study report )
Body weight:
The test item had no impact on the weight of the test animals.
Gross pathology:
see full study report

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
In conclusion, according to the Globally Harmonized Classification System, 2,6-Dimethylphenoxyaceton administered orally in male and female rats under the conditions of this study is considered that 2,6-Dimethylphenoxyaceton has not to be classified with an LD 50 of 2880 mg/kg bw.