Tetramethylammonium hydrogen phthalate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1987-July 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. Test substance only indicated by abbreviation; no information on test substance purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

no information on test substance purity

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetramethylammonium hydrogen phthalate

EC Number:

416-900-5

EC Name:

Tetramethylammonium hydrogen phthalate

Cas Number:

79723-02-7

Molecular formula:

C12H17NO4

IUPAC Name:

tetramethylazanium 2-carboxybenzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): TMAP
- Physical state: white crystalline powder
- Storage condition of test material: room temperature in sealed container

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire.
- Age at study initiation: approximately ten to fourteen weeks old
- Weight at study initiation: males 234 - 269g, females 208 - 232g
- Fasting period before study: no
- Housing: solid-floor polypropylene cages with sawdust bedding; during exposure housed individually after in groups of 5 by sex.
- Diet: free access to food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K .)
- Water: free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 60 - 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 June 1987 To: 30 June 1987

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: moistened with distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 cm x 12 cm (clipped free of hair).
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a double layer of elastic adhesive bandage {ELASTOPLAST) wrapped around the trunk of the rat.

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin and surrounding hair was wiped with moist absorbant paper to remove any residual test material .
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for overt signs of toxicity and mortality 1 and 4· hours after dosing and subsequently at least once daily for fourteen days. Individual bodyweights were recorded on the day of treatment (day 0) and on days seven and fourteen.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: No signs of systemic toxicity or skin irritation were noted during the study period.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on an acute dermal toxicity test with TMAP faccording to OECD guideline 402, the acute dermal median lethal dose (LD50) of TMAP in the rat was found to be greater than 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study in rat performed according to OECD guideline 402, TMAP was tested in 5 rats/sex at the limit dose of 2000 mg/kg bw (semi-occluded application) for 24 hours. No deaths occurred. No signs of systemic toxicity or skin irritation were noted during the study. The animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy of animals killed at the end of the study period. The acute dermal median lethal dose (LD50) of the test material in the rat was found to be greater than 2000 mg/kg bodyweight.