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Toxicological information

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:
20 June 1979 - 12 July 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Information on substance identity is not based on 12042-91-0. Composition is not available. NON - Guideline study. Non- GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
test material certificate of analysis not included
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Locron P
- Physical state: Solid
- Molecular formula (if other than submission substance): Al2(OH)5Cl.2-3H2O
Specific details on test material used for the study:
- Storage condition of test material: in the dark at 20 degrees celsius

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF-Wistar (Hoe: WISKf(SPF71))
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 182 - 191 g
- Fasting period before study: Not reported
- Housing: individual Makrolon cages with wood shavings
- Diet: Rattendiät Altromin 1324 (ad libitum)
- Water: tap water, in plastic bottle (ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 2) °C
- Humidity (%): 50 (+/- 10) %
- Air changes (per hr): partially air-condioned rooms
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: To: Not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
deionised
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm²
- % coverage: aluminium foil (6 x 8 cm) additional elastic plaster bandage
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes. the treated skin area was rinsed with lukewarm water to remove the remaining test substance
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL
- Concentration (if solution): 40% suspension
- Constant volume or concentration used: yes

VEHICLE: deionised water
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes. At the end of the observation period, the surviving experimental animals were killed by CO2 gas, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No symptoms of poisoning were observed at any time during the follow-up period
Gross pathology:
The macroscopic assessment of the animals killed at the end of the observation period revealed that all animals had a lung with dark red spots (= increased blood-flow). Experience has shown that this finding is not substance-related and results from the method of asphyxiation used.

Any other information on results incl. tables

For raw data, see attached full study report

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the acute dermal LD50 of Locron P towards female Wistar rats is > 2000 mg/kg bw. Therefore, it is not classified according to the annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute dermal toxicity study according to methodology comparable to OECD Guideline 402, 6 female Wistar rats were exposed to Locron P at 2000 mg/kg bw during 24 hours. After the exposure period, the dressing was removed and the treated skin area was rinsed with lukewarm water to remove the remaining test substance. At the end of the observation period, the surviving experimental animals were killed by CO2 gas, dissected and examined for macroscopically visible changes.

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

Dark red spots in lung (= increased blood-flow) were observed in all animals. Experience has shown that this finding is not substance-related and results from the method of asphyxiation used.

LD50 was found to be > 2000 mg/kg bw

Under the test conditions, the acute dermal LD50 of test substance Locron P is higher than 2000 mg/kg bw. Therefore, the test substance is not classified according to the annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.