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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited details on the experimental procedure. Confidence intervals calculated. The experiments for the three age groups all yielded similar LD50s giving some confidence in the repeatability (ignoring possible statistically significant age effects).

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity and limits of solvent residue for sixteen organic solvents
Author:
Kimura, E.T., Ebert, D.M., Dodge, P.W.
Year:
1971
Bibliographic source:
Toxicology and applied pharmacology, 1971, 19, 699-704

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only observed for 7days after dosing.
Principles of method if other than guideline:
16 solvents administered orally (via syringe) to newborn, immature, young adult and adult rats. LD50 values were calculated by the method of Litchfield (Litchfield, J.T. et al, J.Pharmacol.Exp.Ther., 1949, 96, 99-101).
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: commercial solvents, analytical grade

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Four different ages were tested; newborn and "older adult" were male only:
- Age at study initiation: 24-48h, 14d, "young adult", "older adult"
- Weight at study initiation: 5-8g, 16-50g, 80-160g, 300-470g
- Fasting period before study: nonfasted

Administration / exposure

Route of administration:
other: needle or microsyringe
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
6 male animals per study in young and older adults.
6-12 mixed sex animals per study in newborn and 14d olds.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
95% CL:
860 - 2 400
Remarks on result:
other: 14d old
Sex:
male
Dose descriptor:
LD50
Effect level:
1 700 mg/kg bw
95% CL:
1 400 - 1 900
Remarks on result:
other: young adult
Sex:
male
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
95% CL:
1 100 - 1 400
Remarks on result:
other: older adult
Other findings:
- Other observations: LD50s for newborns could not be determined due to minimum administration volumes. Generally given as ca. LD50<1mL/kg bw.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information if swallowed Criteria used for interpretation of results: other: CLP (REGULATION (EC) No 1272/2008)
Conclusions:
LD50s converted from mL/kg bw to mg/kg bw.