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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June-July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and it was compliant with GLP. The study is read across from the calcium sodium salt of DTPMP (CAS 52871-36-0).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
52871-36-0
Cas Number:
52871-36-0
IUPAC Name:
52871-36-0
Constituent 2
Reference substance name:
DTPMP Ca Na
IUPAC Name:
DTPMP Ca Na
Details on test material:
- Name of test material (as cited in study report): SPE9806 (Dequest 2066) - calcium salt, Diethylenetriamine penta(methylene phosphonic acid) Calcium, sodium salt

- Physical state: white powder / amber liquid

- Storage condition of test material: room temperature, in a lined or plastic container (not metal), in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.49-3.09kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 - 70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal/flank area
- % coverage: ca. 10%
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.61 ml/kg

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. After removal of the dressing and from there after the test sites were examined for evidence of primary irritation and scored according to Draize (1977). Individual body weights were recorded prior to application of the test material on Day 0, 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The gross pathological examination consisted of an external examination and opening of the abdominal and thoracic cavities. The appearances of any macroscopic abnormalities were recorded. No tissues were retained.
Statistics:
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

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.
Clinical signs:
There were no signs of systemic toxicity or of dermal irritation.
Body weight:
All animals showed expected body weight gains over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
An acute dermal toxicity LD50 value of >2000 mg/kg is reported in a guideline study which was conducted in compliance with GLP. The result is read across from the calcium/sodium salt of DTPMP (CAS 52871-36-0).