Sodium 2-ethylhexanoate

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:

Oct - Nov 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexanoic acid

EC Number:

205-743-6

EC Name:

2-ethylhexanoic acid

Cas Number:

149-57-5

IUPAC Name:

2-ethylhexanoic acid

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2 ethylhexan säure
- Physical state: liquid
- Analytical purity: >99 %
- Lot/batch No.: IRAE 105

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 7 weeks (males) 9 weeks (females
- Weight at study initiation: 208 +/- 4 g (males); 191 +/- 3 g (females
- Fasting period before study: no
- Housing: single in macrolone cages (Type 3) on wooden bedding
- Diet (e.g. ad libitum): ad libitum Altromin 1234 (Altromin GmbH, Lage/Lippe)
- Water (e.g. ad libitum): tab water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage:
- Type of wrap if used: alu folie, fixed by tape (Fixomull; Elastoplast; Fa. Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml pure substance (desity 0.9 g/ml)

Duration of exposure:

24 h

Doses:

2000 mg/kg

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: observation : daily; weighing prior to application on day 7 and day 17 (Study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not necessary

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality

Clinical signs:

other: no clinical symptoms besides eshar formation in two females from day 5-day 8

Gross pathology:

no substance related macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dermal dose of 2-ethylhexanoic acid wasgreater than 2000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute dermally toxic and is therefore not subjected for labelling and classification requirements according to regulatory requirements.

Executive summary:

A read across was performed from the source substance 2 -ethylhexanoic acid to the target substance sodium 2 -ethylhexanoate (for read across justification please refer to attached document, IUCLID Chapter 13).

2 -Ethylhexanoic aicd was tested for its acute dermal toxicity potential. 5 female and 5 male rats were treated with 2000 mg/kg bw and observed for 14 days.

The median lethal dermal dose of test item (LD50) was greater than 2000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.

Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute dermally toxic and is therefore not subjected for labelling and classification requirements according to regulatory requirements.