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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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Statement is provided for Identity of the test substance - no CAS number or other identification is in report. Composition has to be proved. Non GLP. OECD 402 study. Available CoA Aluminium Chlorohydrate, USP, spec No BH-0450, data May 15, 2007 wich supersedes CoA Sep 2004
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Chlorhydrol ultrafine
- Physical state: Solid (white powder)
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Limited, Wyton, Huntington
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: males: 203 - 215 g; females: 221 - 232 g
- Fasting period before study: No
- Housing: Polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and mouse expanded diet No.1, Special diet services limited, Witham, Essex, U.K., ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 degrees Celsius
- Humidity (%): 45 - 60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 13-01-1986 To: 27-01-1986

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 12 cm on the back and flanks of the body
- % coverage: +/- 10% of the total body surface
- Type of wrap if used: bandage (surgical gauze) tightened with Elastoplast


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no


VEHICLE
- No vehicle was used
Duration of exposure:
14 days
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: after 1 and 4 hours, daily for the remainder of the test; weighinh: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic abnormalities (section)
Statistics:
No data

Results and discussion

Preliminary study:
No data.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
None of the animals showed any observable response during the study period.
Body weight:
No control group was used, therefore no comparison is possible
Gross pathology:
No abnormalities were noted.
Other findings:
No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, the acute dermal median lethal dose to rats of Chlorhydrol ultrafine was found to be greater than 2000 mg/kg bw. Based on these results, the registered substance is not classified according to Regulation EC No.1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute dermal toxicity study performed according to OECD Guideline 402 and in compliance with GLP, groups (5/sex/dose) of Sprague-Dawley rats were tested with a single dermal application of Chlorhydrol ultrafine at 2000 mg/kg bw for 24 hours. Animals were then observed for mortality, clinical signs for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred. No clinical signs were observed. At necropsy, no abnormalities were noted.

The Single Dose Acute Dermal LD50 of Chlorhydrol ultrafine applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Therefore the registered substance was not classified according to the Annex VI of the Regulation EC No.1272/2008 (CLP) and to the GHS.