Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 28 - Feb 17, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Octadecanoic acid, sulfo-, potassium salt
- Test item No.: 14/0449-1
- Physical state/appearance: liquid, brownish
- Analytical purity: 51.92%
- Homogeneity: homogeneous by visual inspection
- Stability: stable under storage conditions
- Expiry date: June 22, 2016
- Storage conditions: room temperature
- Lot/batch No.: 0012127444
- Density: 1.111 g/mL

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Additional strain characteristics: Crl:WI (Han)
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks (males), 12 weeks (females)
- Mean weight at study initiation: approx. 240.6 g (males), 211.8 g (females)
- Housing: single housing in Makrilon cages type III
- Diet: VRF 1 (P) (SDS Special Diets Services, Altrip, Germany), ad libitum (analyses for chemical and microbial contaminants by the manufacturer was performed in quarterly intervals)
- Water: tap water, ad libitum (analyses was regularly performed by the municipal authorities of Heidelberg)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- 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: about 40 cm² (dorsal and dorso-lateral parts of the trunk)
- % coverage: at least 10%
Fur was removed by clipping about 24 h before administration.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.29 mL/kg bw
- Concentration: 100%
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg
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 weighing: shortly before administration, weekly thereafter and on the last day of observation
- Frequency of observations: several times on the day of administration and at least once daily thereafter each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin findings Skin findings (according to Draize)
Statistics:
Calculations were perfomred using Microsoft Excel 2003 and checked with a calculator.

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 occurred.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs of toxicity were observed during clinical examination.
Local skin effects at the application site comprised in one male animal well-defined erythema (grade 2) on study day 1, which decreased to very slight erythema (grade 1) from day 2 until day 3. Four animals revealed very slight erythema (grade 1) from day 1 until day 2, which persisted in one of these animals until day 3. All male animals showed very slight edema (grade 1) on day 1.
Local skin effects at the application site comprised in three female animals well-defined erythema (grade 2) on study day 1, which decreased to very slight erythema (grade 1) on day 2 and persisted in two animals until day 3. The other two animals revealed very slight erythema (grade 1) from day 1 until day 2. Three female animals additionally showed very slight edema (grade 1) on day 1.
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period with the exception of one male and one female, which showed stagnation of body weight during the second post-exposure week (male) or the first post-exposure week (female).
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information