3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 September to 16 October 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with internationally recognised guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

EC Number:

410-290-4

EC Name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Cas Number:

80693-00-1

Molecular formula:

Hill formula: C35H54O6P2 CAS formula: C35H54O6P2

IUPAC Name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): ADK STAB PEP-36
- Physical state: Solid, white powder
- Purity: >99%
- Lot/batch No.: L-10181
- Expiration date of the lot/batch: 1 August 1992
- Storage condition of test material: In the original container; protected from light at room temperature (approx. 20°C)

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: a biological research laboratory
- Age at study initiation: 10 weeks (males); 12 weeks (females)
- Weight at study initiation: 231-244 g (males); 198-214 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon type-2 cages (size: 16.5 x 22 x 14 cm) with standard softwood bedding.
- Diet: pelleted standard rat maintenance diet, ad libitum.
- Water: community tap water, ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hour dark

IN-LIFE DATES: From: To: 17 September to 1 October 1991

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: the back of the animal
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hrs after application the dressing was removed and the skin washed with lukewarm water and dried with disposable paper towel.
- Time after start of exposure: approximately 24 hours

TEST MATERIAL
- Amount(s) applied (weight): 2000mg/kg

VEHICLE
- Amount(s) applied (volume): 4ml

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality: four times during test day 1, and daily during days 2 to15.
Body weight: day 1 (pre-administration), 8 and 15.
Clinical signs: each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2 to 1 5. All abnormalities were recorded. Due to the 24 hour semi-occlusive treatment, the local findings were observed starting with day 2
of the test.

- Necropsy of survivors performed: yes

Statistics:

Not applicable to a limit test.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No signs of toxicity were observed during the test (0/10).

Gross pathology:

No macroscopic abnormalities were observed at the end of the study.

Other findings:

No skin irritation was observed during the test.

Any other information on results incl. tables

No mortality occurred during 15 days of observation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As no mortality occurred during 15 days of observation, the toxicity of ADK STAB PEP-36 was estimated to be greater than 2000 mg/kg.