Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1996-04-15 to 1996-05-02

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance. For justification of read-across and for further details please refer to the read-across report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glyceryl Citrate/Lactate/Linoleate/Oleate

IUPAC Name:

Glyceryl Citrate/Lactate/Linoleate/Oleate

Constituent 2

Reference substance name:

91744-23-9

Cas Number:

91744-23-9

IUPAC Name:

91744-23-9

Details on test material:

- Substance type: product
- Physical state: liquid
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 200 - 300 g
- Fasting period before study: not mentioned
- Housing: conventional, each sex separately, not more than 5 animals/Makrolon cage type III
- Diet (e.g. ad libitum): Ssniff R-10 - Complete feed for rats ad libitum, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not mentioned
- % coverage: approx. 10
- Type of wrap if used: Acrilastik bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and cellulose
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.004 ml/kg
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations 0.5, 1, 2, 3, 4, 5 and 6 hours after application and then daily until day 14 after application; weighing on days 0 (day of application), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: examination of gross macroscopical organ changes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Number of deaths at each dose: 0/5 male; 0/5 female

Clinical signs:

other: none, nothing abnormal was detected on the skin in the application area

Gross pathology:

No alterations related to the test substance were noted

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of was greater than 2000 mg/kg bodyweight. No clinical symptoms occurred.

Executive summary:

The acute dermal toxicity of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) to male and female Sprague-Dawley rats was investigated in a OECD 402 limit test under GLP conditions. The test substance was applied to the skin of five animals per sex in a single dose of 2000 mg/kg bw (semi-occlusive coverage). Total exposure was 24h. Thereafter, the test substance was removed using warm water and cellulose.

Animals were examined for clinical signs 0.5, 1, 2, 3, 4, 5 and 6 hours after treatment. Animals were thereafter daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14 day observation period all animals were subject to necropsy.

During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD0 > 2000 mg/kg bw).