Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
October 1995- January 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP using OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
EC Number:
500-399-6
EC Name:
2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
Cas Number:
158725-44-1
IUPAC Name:
NA
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
F-3014
Batch number 016
Date received 2 October 1995
Description white solid
Storage temperature 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: Charles river (UK) Ltd
- Age at study initiation: 10-14 weeks
- Weight at study initiation: males 242-256 gr; females 200-206 gr
-acclimatisation: 5 days
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): mouse and rat No 1 special diets services Limited WithamEssex (UK) was allowed during the study
- Water (e.g. ad libitum): mains drinking water.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-54
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: specific area not mentioned
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment are and semi-occluded with a piece of BLENDERM wrapped around each end.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes

Duration of exposure:
24 hr
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 0.5, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days (observation regarding death or overt signs of toxicity) .
- Frequency of observations and weighing: Once daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathological examination has been done

Results and discussion

Preliminary study:
not conducted
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
other: no signs of systemic toxicity
Gross pathology:
no abnormalities

Any other information on results incl. tables

see attached file (tables plus results)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information non toxic Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations.
Executive summary:

The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

No symbol and risk phrase are required according to EU labelling regulations.