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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-01-15 and 2015-07-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-conform study according to guideline.

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt
EC Number:
811-773-6
Cas Number:
1713250-52-2
Molecular formula:
C32 H14 N6 O17 S4. xNa. xNH4
IUPAC Name:
[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt

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: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: 220.8 g (male), 199.2 (female)
- Housing: Single housing
- Diet: VRF1(P); SDS Special Diets Services
- Water: tap water ad libitum
- 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:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap: 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: rinsing of the application site with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 3.33 mL/kg bw
- Concentration: 60 g/100 mL

Duration of exposure:
24 h
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: Individual body weights shortly before application (day 0), weekly thereafter and on the last day of observation. Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter.
- Necropsy of survivors performed: yes
-Other: A check for any dead or moribund animals was made at least once each workday.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
No systemic clinical signs were observed during clinical examination. No local skin effects were observed in the animals. Only on study day 1, blue test item residues were noted on the application area.
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period with three exceptions in the female group. These females showed a stagnation of body weight within the first week, but body weights were within the normal range during the second week. Due to the fact that stagnation of body weight is commonly known for females dermally applied, 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.

Applicant's summary and conclusion

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