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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Aug. 26, 1985 to Sep. 9, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a method comparable to OECD guideline 401 and conducted according to GLP. It is a read across study, hence maximum reliability rating of 2 assigned according to ECHA guidance.

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)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
EC Number:
403-470-9
EC Name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
IUPAC Name:
403-470-9
Constituent 2
Reference substance name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
IUPAC Name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
Details on test material:
- Name of test substance (as cited in study report): CYANEX® 923 Extractant (CT-229-85)
- Lot number: 860-12,13

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc.
- Age at study initiation: young adult
- Housing: individually housed in wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
All animals were housed in environment controlled rooms as per "Guide for the Care and Use of Laboratory Animals". A 12 h light-dark cycle was maintained.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Not applicable
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5/sex
Details on study design:
All animals were observed frequently on the day of dosing and twice daily for the remainder of the study. All external signs of toxicity or pharmacological effects were noted. Body weights were recorded initially, on Day 8 and 15 or at death. All animals that died and those sacrificed at termination of the study were subjected to a gross necropsy and all abnormalities were noted. Cage side observations included, but not limited to changes in the fur and skin, eyes and mucous membranes, respiratory system, circulatory system, autonomic and central nervous systems, somatomotor activity, and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occured
Clinical signs:
Diarrhea, salivation, decreased activity, wet abdomen, sore-rectal area, hair loss at abdomen were observed in both males and females. Nasal discharge was observed in one mail. Swollen hind legs and sore hind legs were observed in one female.
Body weight:
Mean body weight increased as compared to initial.
Gross pathology:
No noteworthy findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test substance was found to be >5,000 mg/kg bw in rats (Reagan, 1985).
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance ‘A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide’ in male and female Sprague-Dawley rats. The substance was administered by gavage to each of ten rats at a level of 5,000 m/kg bw. Animals were observed for external signs of toxicity, body weights and mortality. All animals that died prematurely and those sacrificed at termination of the study were subjected to a gross necropsy and all abnormalities were noted. All animals survived the 15 d post-administration observation period. Diarrhea, salivation, decreased activity, wet abdomen, sore-rectal area, hair loss at abdomen was observed in both males and females. Nasal discharge was observed in one mail. Swollen and sore hind legs were observed in one female. Mean body weight increased as compared to initial. No noteworthy findings were observed in gross pathology. Under the study conditions, the acute oral LD50 was found to be >5,000 mg/kg bw (Reagan EL, 1985).