Reaction Products of Dimethyl hydrogen phosphite and Alcohols C14-18, Even, Linear

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 27 November 2014 to 11 December 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Compliant Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Appearance : white solid block
- Purity : 100%
- Expiry date : 03 November 2016
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Males 271 to 287g, Females 201 to 222g
- Housing: in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): Teklad Gloabl Rodent Diet. ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light):12 hours continuous light and 12 hours darkness

IN-LIFE DATES: 27 November 2014 to 11 December 2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occlued with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing ): After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil to remove any residual test material
- Time after start of exposure: 24 hours

Duration of exposure:

24 hour

Doses:

Single dose level of 2000mg/kg

No. of animals per sex per dose:

Five males and Five females dosed at 2000mg/kg/bw

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: gross pathological examination, clinical observations, body weight, dermal reaction

Statistics:

No statistical analysis was performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the course of the study

Clinical signs:

There were no signs of systemic toxicity during the study

Body weight:

Animal showed expected gains in body weight except for one female which showed no gain during the first week but expected gain in body weight in the second week.

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

There were no dermal effects on any of the animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose LD50 of the test item after a single dermal application of both sexes is greater than 2000mg/kg body weight.

Executive summary:

Guideline

A study was performed to assess the acute dermal toxicity of the test material in the Wistar strain rat. The method followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24

February 1987) and Method 83 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Method

A group of ten animals (five males and five females) was given a single 24-hour, semioccluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then

killed for gross pathological examination.

Results

There were no deaths. No signs of systemic toxicity were noted during the study. No signs of irritation noted during the study.

All animals showed expected bodyweight gain during the study. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.