2-butyloctanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28.01.2015 - 11.02.2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

On the basis of all evaluated data, the similarity of all category members of the ISOCARB is justified on basis of the physico-chemical properties, toxicological and ecotoxicological profiles. There is convincing evidence that these chemicals possess an overall common category profile.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid

EC Number:

941-570-9

Molecular formula:

C11H22O2

IUPAC Name:

Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2propyloctanoic acid
- Substance type: pure active substance, multi constituent
- Physical state: liquid
- Storage condition of test material: at room temperature / protected from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 09 -10 weeks old; females: 12 -13 weeks old
- Weight at study initiation: 239 - 248g (males); 200 - 225g (females)
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 1239)
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 02102140831)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ° C
- Humidity (%): 45 -65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2015-01-22 To: 2015-02-11

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: uniformly over an area
- % coverage: 10
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritation adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritation adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the exposure period the residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
To achieve a 100% of active component a correction factor of 1.0593x will be used.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw
To achieve a 100% of active component a correction factor of 1.0593x will be used.

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: Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 1; 8 and 15. Observations for evidence of dermal irritation were made all days.

Statistics:

not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: no clinical signs of toxicity Erythema grade 1 was observed in 1/5 female and 1/5 male animals. Crust was observed in 2/5 female animals. Desquamation was observed in all female and in 4/5 male animals. Scratches were observed in 3/5 animals of each gend

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 was greater than 2000 mg/kg bodyweight in male and female rats.

Executive summary:

Under the conditions of the present study, single dermal application of the Category member 1 Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid to rats at a dose of 2000 mg/kg body weight was associated with no mortality and no signs of toxicity but slight signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid / kg body weight.