Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 21, 2015 to October 06, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
Paste
Details on test material:
- Name of test material (as cited in study report): Vegetable or animal oil, hydrogenated, reaction products with diethanolamine, maleic anhydride and sodium sulphite
- Lot No.: CH 192435/01
- Purity: Not applicable (UVCB)
- Organic Carbon: 30.2%
- Hydrotox No.: 15/5241
- Origin: DACC
- Stability: Stable within the durability and with appropriate storage conditions
- Solubility in water: ~1 g/L
- Appearance: Light beige liquid/paste
- Storage conditions: Ambient temperature, dark, dry
- Expiration date: July 15, 2015
- Safety directions: H315, H319. Use protective clothing: gloves and protection goggles.

Test animals

Species:
rat
Strain:
other: Hsd: Sprague Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6-8 wk
- Weight at study initiation: 176 – 200 g
- Housing: Clear polysulphone H-Temp solid bottomed cages (Techniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.5_38_20 cm during acclimatization period and 42.5_26.6_18.5 cm during the study with nesting material provided into suitable bedding bags, Up to 5 of one sex during acclimatisation; individually caged during the study

- Diet (e.g. ad libitum): 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 55±15%
- Photoperiod: 12 h dark/12 h light
- IN-LIFE DATES: From: September 21, 2015 To: October 06, 2015

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the dorsal surface of the trunk
- % coverage: approximately 10% of body surface
- Type of wrap if used: elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2,000 mg/kg
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
05
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: immediately after the dossing, 1, 2 and 4 h after dosing, and daily thereafter.
- Necropsy of survivors performed: yes.
- Clinical signs: immediately after the dossing, 1, 2 and 4 h after dosing, and daily thereafter.
- Body weight: on the day of dosing (Day 1) and on Days 2, 8 and 15.

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 throughout the observation period.
Clinical signs:
No clinical signs were observed in male or female animals during the 14 d post-dose observation period.
Body weight:
Body weights and body weight changes were within the expected range for this species and age of animals at the end of the study.
Gross pathology:
No abnormalities were found in any animal at necropsy examination performed at termination of the study.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Hsd:Sprague-Dawley CD rats.
Executive summary:

A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague-Dawley rats according to OECD Guideline 402, EU Method B.3 and EPA OPPTS 870.1200,in compliance with GLP. A group of 10 rats (five males and five females) received the test substance at a dose level of 2,000 mg/kg bw dermally through semiocclusive exposure for a period of 24 h. Exposed animals were observed for mortality, clinical signs and body weight changes for 14 d and were then killed and subjected to gross pathological examination. No mortality and clinical signs were noted during the observation period. The body weight changes recorded during the study were within the expected range for this species and age. No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. Under the study conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg (Longobardi C, 2015a).