Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study - original study report available

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dipropylene Glycol Monoethyl Ether
- Substance type: Glycol ether
- Physical state: Clear, colourless liquid
- Lot/batch No.: GOHC Lab. sample No. 1030, Oil Stocks reference No. 08977, 134/109
- Storage condition of test material: Ambient temperature in brown screw cap bottle
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: young adult
- Weight at study initiation: male 106-133 g and females 110-133 g
- Fasting period before study: 1 day
- Housing: Type RC1 cages with grid floors
- Diet (e.g. ad libitum): pelleted diet ad libitum
- Water (e.g. ad libitum): tapwater ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12 h

IN-LIFE DATES: 1985-10-08 to 1985-11-06

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
None
MAXIMUM DOSE VOLUME APPLIED:
7.56 ml/kg
Doses:
2.76, 3.86, 5.40 and 7.56 ml/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs daily, body weight on days 1, 8 and 14
Statistics:
Probit (Finney 1952)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
5.5 mL/kg bw
Based on:
test mat.
95% CL:
4.8 - 6.3
Sex:
female
Dose descriptor:
LD50
Effect level:
4.5 mL/kg bw
Based on:
test mat.
95% CL:
3.4 - 5.6
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 mL/kg bw
Based on:
test mat.
95% CL:
4.2 - 5.7
Mortality:
see above
Clinical signs:
Lethargy, decreased motor activity, prone posture and ataxia or breathing irregularity and unconsciousness. All recovered by day 3.
Body weight:
All survivors made anticipated bodyweight gains.
Gross pathology:
Staining of fur, abnormal GI contents, thymic petechiae and pallor of stomach wall in decedents
Other findings:
No abnormalities

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Slightly toxic.
Executive summary:

After adjustment for relative density (0.9317) the combined male/female LD50 of 5.0 ml/kg and the female LD50 of 4.5 ml/kg (ca 4700 mg/kg and 4200 mg/kg respectively) are above the level for classification as toxic or R22 in EU criteria but are in the range 2000 to 5000 mg/kg for Category 5 Classification under GHS.