[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

Study period:

from Aug. 2001 to 12 Dec. 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

yes

Remarks:

relative humidity sometimes out of the target (minor deviation)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

753480-32-9

Cas Number:

753480-32-9

IUPAC Name:

753480-32-9

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France.
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old.
- Weight at study initiation: 261 ± 11 g for the males and 225 ± 9 g for the females (on the day of treatment).
- Fasting period before study: no
- Housing:
> during acclimation period: 1 to 7 animals/sex in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm).
> during the treatment period: individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm).
- Diet: free access to A04 C pelleted diet.
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 30 to 70% (with minor deviation)
- Air changes: approximately 12 cycles/hour
- Photoperiod: 12 h light/12 h dark

IN-LIFE DATES: From 19 September 2001 (first treatment) to 3 October 2001 (necropsy of the last animal)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area.
- % coverage: approximately 10% of the total body surface.
- Type of wrap if used: gauze pad held by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: yes (with a moistened gauze pad)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Concentration: undiluted
- For solids, paste formed: yes (applied on a hydrophilic gauze pad pre-moistened with 2 mL of water)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

five males and five females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs and mortality: frequently during the hours following administration of the test substance, and thereafter at least once a day until day 15.
> body weight: just before administration of the test substance on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: any local cutaneous reaction was recorded from day 2.

Statistics:

Not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

No deaths occurred during the observation period.

Clinical signs:

No clinical signs and no cutaneous reactions were observed during the observation period.

Body weight:

A reduced body weight gain or a slight body weight loss was seen in 3/5 females between day 1 and day 8, without any relevant consequence at the end of the observation period. The overall body weight gain of the other animals was similar to that of the lab's historical control animals.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50 of the test compound is higher than 2000 mg/kg bw for male and female rats.

Executive summary:

In an acute dermal toxicity study according to OECD TG 402 and GLP (CIT report No. 22319 TAR), scored as validity 1 according to Klimisch criteria, a group of 8-week old Sprague-Dawley rats (5/sex) were applied a single dermal dose of undiluted cerium and iron oxide isostearate at the dose of 2000 mg/kg bw (limit test) under a semi-occlusive dressing applied for 24 hours, and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15. Local tolerance was also observed from Day 2.

Under the experimental conditions, the dermal LD50 of the test substance cerium and iron oxide isostearate is higher than 2000 mg/kg in rats.

No mortality occurred during the observation period. No clinical signs or local effects were reported.

A reduced body weight gain or a slight body weight loss was seen in 3/5 females between day 1 and day 8, without any relevant consequence at the end of the observation period. The overall body weight gain of the other animals was similar to that of the lab's historical control animals. No relevant findings were seen at necropsy on day 14.

 

No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.