Reaction mass of aluminium chloride, iron dichloride, magnesium chloride and manganese dichloride

Acute Toxicity: dermal

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. Compositionhas 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-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chlorhydrol Ultrafine

IUPAC Name:

Chlorhydrol Ultrafine

Details on test material:

- Name of test material (as cited in study report): Chlorhydrol ultrafine
- Physical state: Solid
- Storage condition of test material: At room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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): 2,000 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:

2,000 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:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male

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, so 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:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The 14-D LD50 of Chlorhydrol ultrafine towards male and female Sprague-Dawley rats is > 2,000 mg/kg bw.

Executive summary:

The acute dermal toxicity of Chlorhydrol ultrafine towards male and female Sprague-Dawley rats was investigated in a 14 day limit test according to OECD Guideline 402 under GLP. Rats were exposed to a concentration of 2,000 mg/kg bw. The 14-d LD50 was found to be > 2,000 mg/kg bw.