Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Lecithins, acetylated
EC Number:
293-316-5
EC Name:
Lecithins, acetylated
Cas Number:
91053-50-8
Molecular formula:
Not applicable- complex UVCB substance
IUPAC Name:
91053-50-8
Details on test material:
Purity: Unknown variable composition biological substance (UVCBS)
Composition of test material, percentage of components: Unknown variable composition biological substance (UVCBS)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young Adult (9-11 weeks)
- Weight at study initiation:males 330-359 grams and females 236- 259 grams
- Fasting period before study: Not reported
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 64-79%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dose area of approximately 2 inches x 3 inches
- % coverage: approximately 10% of the body surface
- Type of wrap if used: 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the pads were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: approximately 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- Concentration (if solution): undiluted
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males/5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for mortality, signs of gross toxicity, and behavioural changes 1 and 4 hours after application and at least once daily thereafter for 14 days.
- Frequency of weighing: Prior to test substance application (initial) and again on Days 7 and 14
- Necropsy of survivors performed: All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No adverse effects observed. No deaths, or gross necropsy findings. No clinical signs except transient irritation at dosing site. Transient body weight effects in 2/5 females.
Mortality:
No mortality was observed.
Clinical signs:
Dermal irritation noted at the dose site of one male on Day 1 and all females between Days 1 and 8
Body weight:
Two females lost body weight through Day 7, all animals gained weight over the entire 14-day study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC
Conclusions:
LD50 > 5000 mg/kg

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application. Five thousand milligrams of the test substance per kilogram of body weight was applied to the skin of ten healthy rats (five males and five females) for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioural changes 1 and 4 hours post-dosing and at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. All animals survived exposure to the test substance. Apart from dermal irritation noted at the dose site of one male on Day 1 and all females between Days 1 and 8, there were no other clinical findings recorded for any animal over the course of the study. All animals gained weight over the entire 14-day study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5000 mg/kg of body weight in male and female rats. In accordance with the provisions of Directive 67/548.EEC, classification is not required based on the results of this study. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.