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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.08.1982 to 17.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method: SafePharm protocol (number GM 08/82/53A)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[nitrilotris(methylene)]trisphosphonic acid, sodium salt
EC Number:
243-900-0
EC Name:
[nitrilotris(methylene)]trisphosphonic acid, sodium salt
Cas Number:
20592-85-2
Molecular formula:
General formula C3H12NO9P3.xNa where x=3-5 ATMP-3Na C3H9NNa3O9P3 ATMP-4Na C3H8NNa4O9P3 ATMP-5Na C3H7NNa5O9P3
IUPAC Name:
Sodium salt of [nitrilotris(methylene)]trisphosphonic acid (3-5Na:1)
Test material form:
solid - liquid: aqueous solution
Remarks:
aqueous solution

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A. Tuck & Sons Limited, Essex, UK.
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Males: 219-242 g: Females: 210-232 g.
- Fasting period before study: None
- Housing: Five per polypropylene cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 65-75
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 03.08.1982 to 17.08.1982

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal, lateral and ventral.
- % coverage: No data
- Type of wrap if used: The trunks of the rats were encircled with a strip of elastic adhesive bandage, backed with aluminium foil. The bandage was tightened sufficiently to prevent the animal from wriggling free and wrapped round to form a double layer.


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 hours following dosing. On subsequent days the animals were observed at least once. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
None required.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to >5740 mg active salt/kg bw and >4437 mg active acid/kg bw
Mortality:
No animals died.
Clinical signs:
other: Lethargy and increased red coloured lacrimation in one rat on the day of dosing.
Gross pathology:
No abnormal findings.
Other findings:
None

Any other information on results incl. tables

The dermal LD50 in the rat was determined to be >10 ml/kg bw (reviewer comment: presumed equivalent to >5740 mg active
salt/kg bw).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, the LD50 for ATMP-xNa (aqueous solution containing 41% w/w active salt) was concluded to be >10 ml/kg (equivalent to 5740 mg active salt/kg bw and 4437 mg active acid/kg bw) in rats.