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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

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))
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
other: Japan MAFF 12 Nosan No. 8147
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay, Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515/519, 69120 Heidelberg
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C12-14, α-sulfo, disodium salts
EC Number:
942-523-5
Molecular formula:
Unspecified
IUPAC Name:
Fatty acids, C12-14, α-sulfo, disodium salts
Details on test material:
- Name of test material (as cited in study report): Fatty acids, 12-14, a-sulfo, disodium salt
- Test item No.: 15/0531-1
- Storage: room temperature
- Physical state/color: solid/beige
- Expiry date: April 2018

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: males approx. 8 weeks, females approx. 12 weeks
- Weight at study initiation: mean males 231.2 g, mean females 203.0 g
- Housing: single housing, in Makrolon type III cages; H15005-29 bedding, Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany); NGM E-022 enrichment, ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days before the experimental phase
- Females were nulliparous and non-pregnant

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 40 cm2
- % coverage: 10
- Type of wrap if used: semi-occlusive 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: after removal of the semi-occlusive dressing, the application site was rinsed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.4 mL/kg bw was applied to the clipped epidermis (dorsal and dorsolateral parts of the trunk)
Duration of exposure:
24 hours
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: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Scoring of the skin finding: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times until the last day of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
The body weight of the male animals increased within the normal range throughout the study period. The female animals showed stagnation of body weight in two animals, while in the other three animals a marginal loss of body weight was observed during the first week. Two female animals gained weight in a normal range during the second week, while the other three animals showed stagnation of body weight during the second week. Due to the fact, that stagnation or slight loss of body weight is commonly known for females after dermal applications, this stagnation is considered to be unspecific.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Other findings:
LOCAL EFFECTS:
Four female animals showed well-defined erythema (grade 2) from day 1 until day 2 or 8 after application, which decreased in three of these animals to very slight erythema (grade 1) from day 5 or 12 until day 8 or 14. In the fourth animal well-defined erythema regressed to very slight erythema (grade 1) on day 5, but progressed again to well-defined erythema on day 8, followed by very slight erythema from day 12 until day 14. In the fifth animal, very slight erythema was seen on day 1, only. Very slight edema (grade 1) was noted in four animals from day 1 until day 2. Scaling was noted in three animals on day 5 and persisted in one of these animals until day 6. Additionally, incrustations were noted in three animals from day 8 or 12 until day 14.
Eczema like skin lesions were seen in one animal from day 5 until day 8, while weeping areas of the skin were noted in two other animals on day 1 after application only.

Applicant's summary and conclusion