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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 15, 1984 - May 29, 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP-like quality control

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)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

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:

Unspecified

IUPAC Name:

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

Test animals

Species:

rat

Strain:

other: Rat, 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:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 177-239 g
- Housing: individually in Macrolon cages type 2 with standardized soft wood bedding
- Diet (ad libitum): Rat food, NAFAG No. 890
- Water (ad libitum): drinking water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: skin of the back (Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.)
- Type of wrap if used: gauze lined dressing, which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: mortality (daily, a.m. and p.m. on working days, a.m. on weekends), signs and symptoms (daily)
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

other: Dyspnoea, exophthalmus, ruffled fur, curved and ventral body position were seen, defined as common symptoms in this type of experiment. In addition, a slight sedation and diarrhea was observed. A localised erythema was noted on the site of application. Th

Gross pathology:

No gross lesions were found at necropsy.

Any other information on results incl. tables

Table 1:Body Weights (g) and Standard Deviation

Dose (mg/kg bw)	Day 1	Day 7	Day 14
	Males
2000	212 (16.0)	245 (22.1)	288 (28.3)
	Females
2000	197 (18.3)	200 (17.5)	214 (16.6)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute dermal administration and a 14 day post-treatment observation period, an LD50 of > 2000 mg/kg bw was determined in the rat.