SUMILIZER GP

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Feb - 13 Mar 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

no stepwise dosing approach, 5 animals/sex used

GLP compliance:

yes (incl. QA statement)

Remarks:

The Swiss GLP Monitoring Authorities, Bern, Switzerland

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-450-4

EC Name:

-

Cas Number:

203255-81-6

Molecular formula:

C42H61O4P

IUPAC Name:

6-(3-(3-tert-Butyl-4-hydroxy-5-methylphenyl)propoxy)-2,4,8,1 0-tetra-tert-butyldibenz(d,f)(1,3,2)dioxaphosphepin

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanBrl: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding, Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males) and 12 weeks (females)
- Weight at dosing: 249.3 - 290.2 g (males) and 190.6 - 207.8 g (females)
- Housing: During acclimatization in groups of 5/sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintainance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 20 - 26 Feb 2003
- Microbiological status when known : SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 (values > 70% during cleaning process possible)
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin on the back of the animals
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with a semi-occlusive dressing. The dressing was wrapped around the abdomend and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 0.5 g/mL
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 4 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: The animals were observed daily during acclimatisation and twice daily during Days 1-5 for mortality and viabilitx. Clinical signs of toxicity were recorded daily during acclimatisation and at approx. 1, 2, 3 and 5 h after administration in test Day 1. Thereafter, the animals were observed once daily during Days 2-15.
- Frequency of weighing: On test Days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: Yes. All animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and underwent macroscopic examinations. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

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:

No mortality occurred during the study period.

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified