Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Oct - 04 Nov 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No data on GLP compliance. The exposure was occlusive and skin irritation effects were not determined.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

no assessment of dermal effects, occlusive exposure

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

IUPAC Name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: colourless liquid
- Analytical purity: 100% (UVCB)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nossan, Correzzana MI, Italy
- Weight at study initiation: 185 - 215 g (males); 193 - 211 g (females)
- Housing: the animals were housed in groups of 5 by sex in transparent polycarbonate cages (42.5 cm x 26.6 cm x 18.0 cm).
- Diet: standard pellet complete diet (Nossan, Correzzana MI, Italy), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 25 (maintained at a pressure higher than the outside atmosphere)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 Oct 1993 To: 04 Nov 1993

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm² of the shaved skin of the dorsal part
- Type of wrap if used: the sample was put on a patch (Hansamed strips) that was placed on the shaved skin. The patch was covered by an impermeable and hypoallergenic plastic adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was washed off the skin using a pad soaked in distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: no, adjusted according to individual body weight

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 and weighing: animals were observed for mortality daily (Monday - Friday); clinical signs were monitored daily (Monday - Friday); the body weight was recorded on Day 0 (prior to administration), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (behaviour, external examination, mucous membranes, somatomotor activity, sensory functions)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period.

Clinical signs:

other: No clinical signs were observed up to the end of the 14-day observation period.

Gross pathology:

The necropsy and histopathological examination did not reveal any treatment-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