2,3-dihydroxypropyl laurate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

22 Mar - 07 Apr 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2,3-triyl trisheptanoate

EC Number:

210-647-2

EC Name:

Propane-1,2,3-triyl trisheptanoate

Cas Number:

620-67-7

IUPAC Name:

propane-1,2,3-triyl triheptanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical name: Heptanoic acid triglyceride
- Physical state: pale yellow liquid
- Analytical purity: 97.2%
- Date of production: September 29th, 1992
- Batch No.: 209052
- Expiration date of the lot/batch: October 1993 at the earliest
- Homogeneity: liquid appeared homogeneous on inspection
- Density (20 °C): 0.96 g/cm³
- Stability under test conditions: > 1 year
- Storage condition of test material: in a closed glass vessel in laboratory hood
- Solubility (20°C): not soluble in water

Test animals

Species:

rat

Strain:

other: Bor: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 250-260 g (males), 209-238 g (females)
- Housing: up to 5 animals per cage in Makrolon type III
- Diet: Ssniff R 10 - Complete feed for rats (Ssniff, Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 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: dorsum
- % coverage: 10%
- Type of wrap if used: gauze and acrylastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with warm water and gauze
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.08 cm³/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: several times on Day 0, thereafter daily
- Frequency of weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No signs of systemic toxicity observed.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified