Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Berolamine 715. OECD guideline, GLP principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Remarks:
Following GLP principles; statement SD & QA available
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
EC Number:
629-757-0
Cas Number:
1224966-15-7
Molecular formula:
UVCB, no structural formula can be set
IUPAC Name:
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
Details on test material:
The test material was in the form of a dark brown viscous liquid and was stored in the dark under ambient conditions. The pH value for the test substance was 11.2.

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 (U.K.) Limited
- Age at study initiation: no data
- Weight at study initiation: mean weight for 284g males and 229g females.
- Fasting period before study: not applicable
- Housing: in suspended polypropylene cages with stainless steel grid tops and bottoms beneath which was a polypropylene tray containing absorbent paper.
- Diet (e.g. ad libitum): ad libitu, Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1 with known analysis
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (21-24)
- Humidity (%): 37 (28-58)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the back of the animals
- % coverage: no data
- Type of wrap if used: The test material was placed on a piece of gauze which was then placed over the shaved skin and bound with Sleek occlusive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped with a damp tissue to remove excess test material
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
Duration of exposure:
24h
Doses:
2000 mg/ kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and the animals were weighed at dosing after 7 days and at sacrifice
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no deaths
Mortality:
None
Clinical signs:
No clinical signs were noted at any stage of the test
Body weight:
No effects observed
Gross pathology:
No effects observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kb bw
Executive summary:

The acute dermal toxicity of the test substance was investigated in male and female rats of the Sprague-Dawley strain. A single group of 5 male and 5 female rats was treated at a dose level of 2000 mg/kg bw. There were no deaths and no clinical signs were noted at any stage of the test. LD50 > 2000 mg/kg bw.

It is concluded that the test substance would not pose a hazard of percutaneous toxicity in normal use.