Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt

EC Number:

943-172-0

IUPAC Name:

Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt

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 or test system 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:

other: No clinical signs were observed in male or female animals during the 14 d post-dose observation period.

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).