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Toxicological information

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:
other: 1a The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Briquest 543-33S (heptasodium salt of Diethylenetriamine penta(methylene phosphonic acid)
- Lot/batch No.: PD 4000
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Tuck and Sons Limited, Battlesbridge, Essex, UK.
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: Males: 221-235 g; Females: 202-234 g.
- Fasting period before study: No
- Housing: Individually (during exposure) or in groups of five in polypropylene cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of 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 regions.
- % coverage: No data
- Type of wrap if used: Elastic adhesive bandage backed with aluminium foil.


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 bw
Duration of exposure:
24 hours
Doses:
10 ml/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Skin responses were evaluated 0.5, 1, 2, 3, 4, and 5 hours after removal of the patch and residual test substance, and each day for 14 days.  Body weight was measured on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination.
Statistics:
Not required as no deaths occurred.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Mortality:
No deaths.
Clinical signs:
Lethargy was observed in two animals (one male and one female) on the day of dosing.  From four hours after dosing, no abnormal symptoms observed in any animal. 
Body weight:
Body weight were within normal limits throughout the test period.
Gross pathology:
No abnormal findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In an acute dermal toxicity study (reliability score 1) conducted using a protocol comparable to OECD 402, and to GLP, the LD50 for the sodium salt of DTPMP was >10 ml/kg bw (>5838 mg active salt/kg bw, equivalent to >4602 mg parent acid) in rats.
Executive summary:

In an acute dermal toxicity study (reliability score 1) conducted using a protocol comparable to OECD 402, and to GLP, the LD50 for the sodium salt of DTPMP was >10 ml/kg bw (>5838 mg active salt/kg bw, equivalent to >4602 mg parent acid) in rats.