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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
other: No abnormal observations
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.