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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 May 2017 to 07 Jun 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Commission Regulation (EC) No 440/2008, 30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
Version / remarks:
November 24, 2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay, Labor für biologische Analytik GmbH, 69120 Heidelberg
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, castor-oil mono-, di- and tri-
EC Number:
294-589-3
EC Name:
Glycerides, castor-oil mono-, di- and tri-
Cas Number:
91744-27-3
Molecular formula:
C21H40O5 – C57H104O9
IUPAC Name:
Glycerides, castor-oil mono-, di- and tri-
Test material form:
liquid
Specific details on test material used for the study:
- Name of test item as cited in stury report: Sovermol 320
- Batch identification: 0012756105
- Expiry date: 01 July 2018
- Storage conditions: Room temperature
- Physical state/ color: Liquid, light viscous / brownish, clear
- Content: ca. 95 % (100% minus water content)

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han) SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: 227.4 ± 5.98 g (males) and 203.6 ± 6.73 g (females)
- Housing: Single housed in Makrolon cage, type III with a bedding of H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany). Wooden gnawing blocks were used as enrichment ((Type NGM E-022); ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien Austria.)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 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: Application to about 40 cm² on the clipped skin (dorsal and dorsolateral parts of the trunk). Clipping of the fur about 24 hours before application.
- % coverage: at least 10% of the 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): with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.04 mL/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made at least once each workday. Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter. Individual body weights shortly before application (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
- Other examinations performed: Scoring of skin findings: Individual readings 30 to 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter several times until the last day of observation. The evaluation of skin reactions was performed according to Draize, J. H. "Dermal toxicity."

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination of both sexes.
Body weight:
The body weights of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with two exceptions. One animal showed stagnation of body weight during the first week, while in another female the body weight slightly decreased during this week. Both animals gained weight in a normal range 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 all animals (5 males and 5 females) examined on the last day of observation.
Other findings:
Very slight erythema (grade 1) was observed in three male and four female animals from study day 1 until study day 2 or 3.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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