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Diss Factsheets

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:
06.12.1990-20.12.1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study in accordance with EPA OTS 798.1175

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Principles of method if other than guideline:
The methods employed in this study were similar to those described in 40 CFR Part 798 , EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
Name of test material (as cited in study report): Coagulant 122 (solid)
Substance type: Clear to pale viscous yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Wayne Rodent Blox and water
Doses:
5.0 g/kg.
No. of animals per sex per dose:
5 rats/cage by sex.
One group of ten (5 male & 5 female) albino rats
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
Male: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: There were no signs of local or systemic toxicity throughout the 14 day observation period.
Gross pathology:
Effects on organs:
No abnormalities were observed at the macroscopic pathology
examination.

Any other information on results incl. tables

Discussion:

Observations:

Males: All animals appeared normal throughout the 14 -day observation period.

Females: All animals appeared normal throughout the 14day observation period.

Gross Pathology:

Males: no gross abnormalities were observed for the animals necropsied at the conclusion of the 14 -day observation period.

Females: no gross abnormalities were observed for the animals necropsied at the conclusion of the 14 -day observasion period.

See also Table

Conclusion:

The test article, when administered as supplied to 5 male and 5 female albino rats, appears to have an acute oral LD50 greater than 5.0 g/kg.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Coagulant 122 (~50% solution), when administered as supplied to 5 male and 5 female albino rats, appears to have an acute oral LD50 greater than 5.0 g/kg.
Executive summary:

Observations & Gross Pathology

Observations:

Males: All animals appeared normal throughout the 14-day observation period.

Females: All animals appeared normal throughout the 14-day observation period.

Gross Pathology:

Males: No gross abnormalities were observed for the animals necropsied at the conclusion of the 14-day observation period.

Females: No gross abnormalities were observed for the animals necropsied at the conclusion of the 14-day observation period.