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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): FAT 66'031/B
- Analytical purity: 88.1%
- Physical state: solid
- Lot/batch No.: BSG ex Pa 34/45
- Stability under test conditions: stable; expiration date: January 1, 1992
- Storage condition of test material: in the original container, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Woelferstrasse 4, CH-4414 Fuellinsdorf
- Age at study initiation: 10 weeks (males), 12 weeks (females)
- Weight at study initiation: 225 - 247 g (males), 200 - 222 g (females)
- Housing: individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: pelleted standard Kliba 343, Batches 77/90 and 78/90 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst); ad libitum
- Water: community tap water from Itingen; ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of the animals
- Preparation: clipping 24 h before application
- % coverage: 10% of the total body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration (if solution): 100%
- 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:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations four times during test day 1, and daily during days 2 - 15; weighing on test days 1 (pre-administration), 8 and 15
- 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
Mortality:
No mortality occurred.
Clinical signs:
No systemic signs were observed in the animals during the entire observation period.
Skin observations: males/females: scales (back) (10/10); general erythema (back) (3/10); males: erythema focal (back) (3/5). All animals had recovered from the local signs after 7 observation days.
Body weight:
Mean body weight (g): days 1, 8, 15
- males: 236.2, 265.2, 294.8
- females: 207.3, 214.0, 217.8
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the acute dermal toxicity study in rats (limit test), the dermal LD50 is > 2000 mg/kg bw and, thus, classification for acute dermal toxicity is not warranted.