Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Aug 2016 to 9 Sep 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

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:
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:
Reaction mass of Amines, C10-14-branched and linear alkyl, [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-)
EC Number:
939-191-9
Molecular formula:
C32H18CrN6O8.C10-15H21-31NH2
IUPAC Name:
Reaction mass of Amines, C10-14-branched and linear alkyl, [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-)
Specific details on test material used for the study:
- Name as cited in study report: Orasol Black X51
- Test item No.: 16/0074-1
- Batch identification: 001-150606
- Content: App. 95 % can be assumed.
- Expiry date: May 26, 2020
- Storage conditions: Room temperature
- Physical state/ color: Solid / black

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: male animals approx. 8 weeks, female animals approx. 12 week
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight): 225 to 241 (males) or 200 to 217 (females)
- Housing: Single housing in Makrolon cage, type III with Wooden gnawing blocks (Type NGM E-022) ; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria as enrichment. As bedding material H 15005-29 was added; Ssniff, spezialdiäten GmbH (Experimeental Diets INc. 59494 Soest, Germany)
- 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:
corn oil
Remarks:
Ph.Eur.
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm²
- % 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).
- Clipping of the fur: About 24 hours before application

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Afterwards removal of the semi-occlusive dressing, rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 20 g/ 100 mL (suspension)

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/ kg bw
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
- Mortality: A check for any dead or moribund animals was made at least once each workday.
- Clinical observations: Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter.
- Body weight determination: Individual body weights shortly before application (day 0), weekly thereafter and on the last day of observation.
- Scoring of skin findings: Individual readings for skin findings 30 to 60 minutes after removal of the semi-occlusive dressing (day 1), and several times thereafter and on the last day of observation.
- Pathology: 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.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
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.
Body weight:
The body weights of the male animals and of two female animals increased within the normal range throughout the study period. Two female animals showed a stagnation of body weight during the first week while in another female a marginal loss of body weight was noted. The body weights of the affected females increased in a normal range during the second week. Due to the fact that stagnation or marginal 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: Due to the black discoloration of the application area, no erythema could be determined from study day 1 until study day 2 in all animals. Thereafter, no local effects were observed in all animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met