Registration Dossier

Diss Factsheets

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb. 1987
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted May 2008
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
adopted August 1998
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
EC Number:
942-330-6
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
Details on test material:
- Name of test material (as cited in study report): Reaction mass of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine
- Physical state: viscous light brown to clear liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (For details see analytical report BASF study-No.: 13L00017)
- Purity test date: Feb.-April 2013
- Lot/batch No.: D987-AM-202011
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wega GmbH, Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: on average: 227.6g (males), 203.4g ( females)
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad lib., SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: app. 40cm² (= at least 10% of body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing with warm water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.58mL/kg b.w.

Duration of exposure:
24h
Doses:
5000mg/kg
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: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: scoring of skin findings according to Draize (30-60min after removal of the dressing and several times until the end of the study)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occured
Clinical signs:
No systemic toxicity was observed in males or females.

In all male animals moderate erythema (grade 3) was noted on study day 2 and 3 and persisted in one animal until study day 8 and decreased in this animal to well defined erythema (grade 2) until study day 13 and very slight erythema (grade 1) on study day 14. Furthermore well-defined erythema (grade 2) was observed in one out of the five animals on study day 6 and 7 which decreased to very slight erythema on study day 8.
From study day 2 to study day 3 slight edema (grade 2) was observed in four animals. The fifth animal showed slight edema (grade 2) on day 2, which increased to edema grade 3 from day 3 to day 7, decreased to grade 2 again on day 8, and to grade 1 on study day 9. Incrustations were observed in all animals from study day 3 until study day 10, 13 or 14. Scaling was noticed from study day 3 until study day 14 in all male animals while severe scaling was noted in one of these animals on study day 9.

In all female animals moderate erythema (grade 3) was noted on study day 2 and 3 and persisted in three animals until study day 7 or 8. Furthermore well-defined erythema (grade 2) was observed in all females, varying either from study day 6 to 9, 8 to 13, 8 to 9 or only on study day 6 or 9. Erythema decreased in all females to very slight erythema (grade 1) and was noted on study day 7 and 10 or only on day 10 or 14. On study day 2 or 3 slight or moderate edema (grade 2 or 3) was observed in all females and persisted in four females until study day 7 or 8. Very slight edema (grade 1) was seen in three animals on study day 8 or on study days 9 and 10. Incrustations were observed from study day 2 until study day 10 or 14 in all females. Scaling was noticed from study day 3 until study day 13 or 14 in all female animals, while severe scaling was noted in one of these females on study day 9.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
Mean body weight of the female animals stagnated during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information