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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
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 401
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-1-methylethyl acetate
EC Number:
203-603-9
EC Name:
2-methoxy-1-methylethyl acetate
Cas Number:
108-65-6
Molecular formula:
C6H12O3
IUPAC Name:
2-methoxy-1-methylethyl acetate
Details on test material:
- Name of test material (as cited in study report): Methyl Proxitil Acetate
- Substance type: solvent
- Physical state: colourless clear liquid
- Analytical purity: Comparisons of the infra-red spectra revealed no changes
- Impurities (identity and concentrations): Alcohol: 0.016% m/m, water: 200 ppm, HAC: 180 ppm, Unknowns: < 0.1% m/m, Peroxides: 1-12 ppm
- Composition of test material, percentage of components: MPA-1: 1.27% m/m, MPA-2: 98.6% m/m
- Lot/batch No.: U5126
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: stored in the dark at room temperature

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 9-11 weeks old
- Weight at study initiation: Males: 203-244 grams, Females: 130-153 grams
- Fasting period before study: yes, fasted for 18 hours prior to dosing
- Housing: group housed, 2-3 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light:dark cycle

IN-LIFE DATES: From: April 9, 1985 To: June 7, 1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was administered undiluted
Doses:
1564, 2487, 3955, 5000, 6289 and 10000 mg/kg
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation and body weights recorded on days 0, 7 and 14
- Necropsy of survivors performed: no
Statistics:
Finney's probit analysis

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
6 190 - 10 000 mg/kg bw
Remarks on result:
other: LD50 not calculable
Sex:
female
Dose descriptor:
LD50
Effect level:
5 155 mg/kg bw
95% CL:
3 994 - 6 492
Remarks on result:
other: none
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 190 mg/kg bw
95% CL:
5 465 - 7 553
Remarks on result:
other: none
Mortality:
1564 mg/kg - no mortality observed (0/5 + 0/5 - 0/10)
2487 mg/kg - no mortality observed (0/5 + 0/5 - 0/10)
3955 mg/kg - no mortality observed (0/5 + 0/5 - 0/10)
5000 mg/kg - 3 females on day 4 (0/5 + 3/5 - 3/10)
6289 mg/kg - 1 female on day 3 and 3 females on day 4 (0/5 + 4/5 - 4/10)
10000 mg/kg - 1, 3 and 1 male on days 1, 2 and 3 and all females on day 1 (5/5 + 5/5 - 10/10)
Clinical signs:
other: Signs included gait abnormalities, increased lacrimation and/or salivation, unkept appearance and coma, refer to attachment for further details
Gross pathology:
no data
Other findings:
- Organ weights: not examined
- Histopathology: not examined
- Potential target organs: not examined

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of Methyl Proxitiol Acetate to male F344 rats was 6289-10000 mg/kg (LD50 was not calculable), for females was 5155 mg/kg (3994-6492 mg/kg) and for combined male and female F344 rats was 6190 mg/kg (5465-7553 mg/kg) and hence not classified
Executive summary:

In this acute oral toxicity study, groups of F344 rats (5 males + 5 females) were administered Methyl Proxitol Acetate (undiluted) at doses of 1564, 2487, 3955, 5000, 6289 and 10000 mg/kg and observed for 14 days. Observations were limited to daily recording of clinical signs of toxicity, body weight recording on days 0, 7 and 14. Necropsy was not done on any of the animals (surviving and those dying/found dead during the study). Clinical signs included gait abnormalities, increased lacrimation and/or salivation, unkept appearance and coma during the study period and all surviving animals had gained weight relative to their day 0 body weights by the end of the 14 day observation period. Under the conditions of the study, the LD50 of Methyl Proxitiol Acetate to male F344 rats was 6289-10000 mg/kg (LD50 was not calculable), for females was 5155 mg/kg (3994-6492 mg/kg) and for combined male and female F344 rats was 6190 mg/kg (5465-7553 mg/kg) and hence not classified

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