Distillation residue, butyl alcohols production, rectification

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2010-05-30 TO 2010-07-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An acute dermal toxicity study according to OECD technical guideline 402, following GLP, dermal absorption observed at the end of study.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 402: Acute dermal toxicity

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Distillation residue, butyl alcohols production, rectification

EC Number:

931-740-0

Molecular formula:

undefined (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Distillation residue, butyl alcohols production, rectification

Details on test material:

A composite sample, consisting of 5 sub-samples taken over a period of 3 consecutive days, was collected directly from the process line. The volume of each sub-sample was approximately 5-10 L. The sub-samples were combined, resulting in a total volume of ca. 50 L. This ca. 50 L composite sample was split into two equal portions of ca. 25 L each (control sample and laboratory sample). The ca. 25 L laboratory sample was further split into two portions of ca. 5 L and 20 L before sending for analysis at two separate laboratories. After sampling and sample splitting, all the portions of the composite sample were stored at +4 deg Celsius.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited Breeding Velaz Prague Czech Republic
- Age at study initiation: no data
- Weight at study initiation: 190-210g females, 220-290g males
- Fasting period before study: overnight
- Housing: Animals were housed in experimental animal house on the bedding (wooden grate) in groups by maximum of 3 in cage in conformity with laboratory animals welfare legistlation.
- Diet (e.g. ad libitum): ad libitum. A standard certified laboratory diet (supplier Top Dovo, Dobra Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

Acute dermal toxicity

Doses:

Fixed dose 2000 mg/kg bodyweight

No. of animals per group:

5

Control animals:

no

Remarks:

not required

Details on study design:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 2
- Humidity (%): 55 +-10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 30 May 2010 To: 22 July 2010

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of total body surface
- Type of wrap if used: porous gauze patch covered with nonpermeable folio by means of a semi-occlusive dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): fully absorbed

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,440 - 0,670 ml
- Concentration (if solution): undiluted
- Constant volume or concentration used: no, adjusted by body weight

VEHICLE
- Amount(s) applied (volume or weight with unit): undiluted

14 days
Fixed dose 2000 mg/kg bw
*
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: first 30 minutes, periodically the first 24 hours and daily until 14 days. Bodyweights measured at the beginning, after one week and the end of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Signs and symptoms of toxicity:

no effects

Dermal irritation:

no effects

Any other information on results incl. tables

Test compound was fully absorbed without residuum. Any excessive irritation was not observed in the site of application after removing of semiocclusive bandage.

Applicant's summary and conclusion

Conclusions:

Test compound was fully absorbed, with no excessive irritation.