Fatty acids, C16-18 (even numbered), esters with 1,2-propanediol

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:

09 Jun-25 Jun 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP-Guideline study, tested with the source substance Octanoic acid ester with 1,2-propanediol, mono- and di- (CAS 31565-12-5). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, 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:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (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:

31565-12-5

Cas Number:

31565-12-5

IUPAC Name:

31565-12-5

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 247 - 259 g (males) and 231 - 252 g (females)
- Housing: animals were housed individually in Makrolon III cages.
- Diet: Ssniff R 10 (Alleindiät für Ratten, 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: clipped skin of the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: The test material was held in contact with the skin with an acrylastic bandage.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.06 cm³/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 30 min, 1, 2, 3, 4, 5 and 6 h post application and subsequently once daily. Individual body weights were determined on the day of application (Day 0) and on Day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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: 48 h after application 2 male and 1 female animal showed scaling. Scales were not apparent at the 72 h observation time point.

Body weight:

other body weight observations

Remarks:

Body weight gains were within the normal ranges in males and females during the whole study period.

Gross pathology:

Necropsy revealed no substance-related findings. One male animal showed a slight swelling of the spleen possibly due to the termination of the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.