Nitrilotrimethylenetris(phosphonic acid)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Conducted prior to adoption of OECD test guidelines.

Deviations:

yes

Remarks:

Limited details on methods and animal conditions.

Principles of method if other than guideline:

Method: other: Not stated. Insufficient detail to fully assess comparability with OECD guideline.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: Males: 2.3-2.5 kg. Females: 2.0 and 2.1 kg.
- Fasting period before study: No data
- Housing: Individually (cage type to stated)
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: "plastic strips"


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 25% aqueous solution
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 25% solution

Duration of exposure:

24 hours

Doses:

1000, 1580, 2510, 3980 and 6310 mg/kg bw

No. of animals per sex per dose:

One

Control animals:

no

Details on study design:

- Duration of observation period following administration: Not clear, but at least five days.
- Frequency of observations and weighing: Body weights appear to have been measured prior to dosing and five days after dosing.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and gross pathology of animals that die.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 310 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred at any dose.

Clinical signs:

Activity and appetite were temporarily reduced after doses of 3980 and 6310 mg/kg bw.

Body weight:

No apparent effects.

Gross pathology:

No deaths so not conducted.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a well conducted acute dermal study (reliability score 2), conducted according to a protocol similar to OECD 402, but not to GLP, a dermal LD50 of >6310 mg/kg bw was determined for ATMP-H (Dequest 2000) in the rabbit.

Executive summary:

In an acute dermal toxicity study conducted prior to the adoption of OECD test guidelines and GLP, Dequest 2000 was applied to the clipped, intact skin, under an occlusive dressing, for up to 24 hours, at doses of 1000, 1580, 2510, 3980 and 6310 mg/kg bw (one New Zealand white rabbit per dose). The animals were then observed for clinical signs of toxicity (no further details). There were no deaths and therefore no macroscopic examination was conducted. Activity and appetite were temporarily reduced in the two highest-dose animals. The LD₅₀ was >6310 mg/kg bw.