Corn oil (Zea mays, Gramineae), peroxidised

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 3 January 2011 to 18 February 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

corn oil, peroxidised

IUPAC Name:

corn oil, peroxidised

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: from 210 to 255 g
- Fasting period before study: no
- Housing: in transperent macrolone cages (type 3-180, floor area 810 sq.cm) with 2 or 3 in each cage, males and females separated.
- Diet: pelleted complete rodent diet "Altromin 1324", ad libitum
- Water: free access to bottles with domestic quality drinking water, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature:22°C +/- 3°C
- Humidity: at least 30% and preferably not exceeding 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 18 January 2011 (arrival of the animals) to 16 February 2011

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage: no data
- Type of wrap if used: 4-layer gauze pack fixed with Micropore tape wound around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: yes (with mild soap and lukewarm water)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Concentration: undiluted

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

pilot study: 1 female
main study: 5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs: 1, 3 and 6 hours after the start of the application and thereafter once daily for a period of 14 consecutive days
> body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Preliminary study:

The animal included in the pilot study survived to the treatment.
The rat had a normal body weight gain during the study period.
On day 0 after 1 hr, 3 hrs and 6 hrs, the animal showed lower activity (apathy) probably caused by limited mobility resulting from the tape fixation of the patch. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
The post mortem inspection revealed no pathological abnormalities.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no mortality

Mortality:

Neither male nor female rats died on account of the treatment or showed severe signs of toxicity.

Clinical signs:

The animals showed lower activity (apathy) probably caused by limited mobility resulting from the tape fixation of the patch on day 0 after 1 hr, 3 hrs and 6 hrs. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.

Body weight:

The rats had a normal body weight gain during the study period.

Gross pathology:

The post mortem inspection revealed no pathological abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 of peroxidised corn oil in rats was found to be above 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study according to OECD TG 402 and GLP (Vaeth A., 2011), groups of Wistar rats (5/sex) were dermally exposed to undiluted peroxidised corn oil for 24 hours to 6x8cm at the dose of 2000 mg/kg bw (limit test).  Animals then were observed for 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the 2-week observation period, the animals were killed and subjected to gross necropsy examination.

 

Male/female LD50 > 2000 mg/kg bw

 

Neither male nor female rats died on account of the treatment or showed severe signs of toxicity.

The animals showed lower activity (apathy) probably caused by limited mobility resulting from the tape fixation of the patch on day 0 after 1 hr, 3 hrs and 6 hrs. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.

The rats had a normal body weight gain during the study period.

The post mortem inspection revealed no pathological abnormalities.

No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.