[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

458-880-0

EC Name:

-

Cas Number:

85209-93-4

Molecular formula:

Hill formula: C29 H42 O4 P Li

IUPAC Name:

2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo- [d,g][1,3,2]dioxaphosphocin 6-oxide, lithium salt

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley origin (Crl:CD (SD) IGS BR)
- Source: Charles River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: at least 200 g
- Housing: in solid-floor polypropylene cages furnished with woodflakes. Individual housing during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): standard laboratory rodent diet (Certified Rat and Mouse Diet (Code 5LF2))
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

back and flanks
- approximately 10% of total body surface area
- Type of wrap if used: surgical gauze semioccluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):200 mg/ml w/v
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 ml/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

10 rats (5 of each sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation 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 dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: local dermal irritation (erythema, eschar formation, oedema formation), any other lesion or reaction (spots, scabbing)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

none

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

no abnormalities

Other findings:

no signs of dermal irritation

Applicant's summary and conclusion

Interpretation of results:

other: LD50 > 2000 mg/kg

Conclusions:

No labelling regarding acute dermal toxicity according to Regulation (EC) No 1272/2008 is required.