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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
December 4, 1975 - December 19, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets the EC Standards (conducted equivalent to OECD 401). Deviations: lack of study design details in the report, no body weight measurements, no clinical examinations and no necropsy carried out. Only a very short description is reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of several study design details in the report, no body weight measurements, no clinical examinations and no necropsy carried out
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
other: aqueous solution
Details on test material:
- Physical state: Aqueous solution
- Appearance: No data
- Composition of test material, percentage of components: see section confidential details on test material

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
5 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 38%
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 350 mg/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 38%
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 033 mg/kg bw
Based on:
other: expressed as solid content
Mortality:
0/10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity limit study in rats conducted equivalent to OECD 401, the LD50 was determined to be > 5 mL/kg bw, converted to be > 5350 mg/kg bw (as the density is 1.07 g/mL). This corresponds to a LD50 of > 2033 mg/kg bw, when expressed as solid content.