Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-07-09 - 2002-07-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Remarks:
2000-04-26
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Synonyms: ITC 908, vinylidenephosphonic acid tetrasodium salt (VDPA tetrasodium salt)
- Lot/batch No.of test material: 562CH/646
- Purity: 87.33%
- Storage condition of test material: Room temperature, in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: at least 220g
- Fasting period before study: No
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes. Housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Certified Rat and Mouse Diet supplied by IPS Product Suppliers Limited, Wellingborough, Northants, UK, ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
The test material was weighed out according to each animal's indvidual bodyweight and moistened with distilled water prior to application.
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 10
- Type of wrap if used: self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24h

TEST MATERIAL
- For solids, paste formed: yes
Duration of exposure:
24h
Doses:
2000 mg/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:
* The animals were observed for deaths or overt signs of toxicity 30min, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
*After removal of the dressings and subsewuently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to Draize
*Individual bodyweights were recorded prior to application of test material on Day 0 ad on Days 7 and 14.
- 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 was observed.
Clinical signs:
There were no signs of systemic toxicity.
There were no signs of dermal irritation (all scores for females and males for Edema and Erythema were all 0).
Body weight:
All animals showed expected gains in bodyweight.
Gross pathology:
No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bw.
Executive summary:

The acute dermal median lethal dose (LD50) of the test material was found to be greater than 2000 mg/kg bw. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity.