Alkaline earth metal and zinc hydroxy(substituted)alkanoate and oxoalkanoate

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-11-20 to 1999-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministerium für Raumordnung, Landwirtschaft und Umwelt des Landes Sachsen-Anhalt (May 14, 1998)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: crystalline

Specific details on test material used for the study:

The test article was stored in a closed vessel at room temperature in the dark.
A formulation was not necessary, because the original test article was administered. All doses were expressed in terms of the test article as supplied.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH (D-97320 Sulzfeld)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 35-42 days
- Weight at study initiation: males: 291.8 g +/- 9.8 g, n=5
females: 199.8 g +/- 3.1 g; n=5
- Housing: Altromin Type S8/15, granulated soft wood bedding; the animals were housed in groups of up to 3 to a cage seperately according to sex during acclimatisation. From shaving until sacrificing a single animal was housed per cage.
- Diet (e.g. ad libitum): Altromin 1326, pelleted standard diet, Batch# 150299/1351
- Water (e.g. ad libitum): tap water (municipal supply)
- Acclimation period: 13 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22.5 °C
- Humidity (%): 45 - 70%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 our light and 12 hours dark, the light phase was from 6.30 a.m. - 6.30 p.m.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm (trunk)
- Type of wrap if used: covered with aluminium foil (6.5 x 6.5 cm) which was fixed in place with sticking plaster (Lohmann GmbH & Co, Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 g test item/ 100 g body weight. Individual doses were adjusted according to body weight on the day of administration
- For solids, paste formed: no

VEHICLE
- the gauze patch was moistened with distilled water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). Animals were also observed for erythema and /or oedema at the skin of the application area one hour after patch removal and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation all animals were killed by CO2 inhalation. All animal were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined marcorscopically.
- Other examinations performed: clinical signs, body weight, macroscopic pathology

Statistics:

Body weights: Calculation of group mean values and standard deviations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No animal died during the course of investigation.
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:

Clinical observations: No clinical signs were observed during the cours of investigation.

Body weight:

The body weight gain of the male and female animals was in the renage of th historical control data in the test facility.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Other findings:

Skin of the application area: The skin of the application area was not altered.

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

The dermal LD50 in the rat is > 2000 mg/kg bw. The test item in neither a toxic not a hamful substance according to this acute dermal toxicity study.

Executive summary:

Determination of the acute dermal toxicity of the test item was conducted according to OECD guideline 402 and EU method B.3 under GLP compliance. The test item was tested in five female and five male Cooles River Wistar rats, applied at a single dose of 2000 mg/kg body weight. The application to a shaved dorsal area of the trunk of the animals was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure was for 24 hours. The area to which it was applied was then washed with water. Animals were examined for mortality, clinical signs, alterations of the application area, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died during the course of the investigation. Clinical signs, skin alterations on the application area or pathological findings at necropsy were not observed. The body weight gain was not affected.

The dermal LD₅₀ in the rat is > 2000 mg/kg bw.