Amines, C12-14-alkyl, C6-10-alkyl phosphates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

EC Number:

279-632-6

EC Name:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Cas Number:

80939-62-4

Molecular formula:

na (UVCB)

IUPAC Name:

Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source of animals: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initiral body weight range: 177-239 g
Initial age: 7-8 weeks
Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macrolon cages type 2 with standardized soft wood bedding (Societe Parisienne des
sciures, Pantin). The animal room was air conditionned: temperature 22+3C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.
Food: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the substance according to OECD Guideline 402, under GLP conditions. Groups of 5 rats per sex were administered the test substance at a topical dose of 2000 mg/kg bw on the shaved skin of the back with a semiocclusive bandage. The exposure was for 24 h following which the test substance was washed with water and the treated animals were observed for 14 days post dose for mortality, clinical signs, and body weight. Following observation period, the treated animals were sacrificed to observe gross pathological signs in the internal organs. No mortality was observed througout the study. Under the study conditions, the acute dermal LD50 of the substance was determined to be greater than 2000 mg/kg bw (Kobel, 1984).