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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read across, GLP, acc. to Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
see chapter 13
IUPAC Name:
see chapter 13
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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 UK
- Age at study initiation: 7 -8 weeks
- Weight at study initiation: 210 - 300 g
- Fasting period before study: no
- Housing: single polypropylenen cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 42 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
suspension
Details on dermal exposure:
TEST SITE
- % coverage: ca 10
- Type of wrap if used: impermeable plaster arround the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, but wiped with paper towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4mL/kg of a 500 mg/mL suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

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:
other: no mortality observed
Mortality:
none
Clinical signs:
No abnormal observations
Body weight:
Normal development
Gross pathology:
No abnormal observations
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of Brown HH 469 in rats with intact skin was in excess of 2000 mg/kg.
Executive summary:

A study was performed te determine the acute dermal median lethal dose (LD50) of Brown HH 469 in the rat. The study was designed to meet the requirements of Annex V of the EEC Council Directive 79/831/EEC, the Organisation for Economic Co-operation and Developement (OECD), and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

A group of 10 Sprague-Dawley rats (5 males, 5 females) was given a single, 24 hour, dermal application of Brown HH 469 at a dose level of 2000 mg/kg.

No animals died during the 14 day observation period. The acute dermal median lethal dose (LD50) of Brown HH 469 was in excess of 2000 mg/kg.