Hydrocarbons, terpene processing by-products

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-26 February 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 402 without any deviation.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, terpene processing by-products

EC Number:

273-309-3

EC Name:

Hydrocarbons, terpene processing by-products

Cas Number:

68956-56-9

Molecular formula:

Not applicable for UVCB substance

IUPAC Name:

Hydrocarbons, terpene processing by-products

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hydrocarbons, terpene processing by-products
- Physical state: Pale yellow liquid
- Analytical purity: 100% (sum of terpene hydrocarbons 67.9%)
- Lot/batch No.: 129958
- Expiration date: 7 March 2013
- Storage condition of test material: 6 ± 3 °C, darkness, store under nitrogen after opening
- Density: 0.890 g/mL at 19 °C

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Male: 7 weeks; Female: 8 weeks
- Weight at study initiation: Males: 233-250 g; females: 214-227 g
- Housing: During the treatment, the animals were kept in individual cages. On day 1, the animals were put into their cage by 5. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: Foodstuff (SAFE - A04), ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately between ten and fifteen changes per hour
- Photoperiod: 12 h dark / 12 h light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10 % of the body surface area
- Type of wrap if used: Animals from treated group received by topical application, under porous gauze dressing.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Dose volume: 2.38 mL/kg bw
- Constant volume or concentration used: Yes

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:
Clinical signs and mortality: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. Observations and a mortality report were then carried out every day for 14 days.
- The animals were weighed on Day 0 (just before administering the test item) then on Days 2, 7, and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels and all animals were subjected to a macroscopic examination.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred during the study.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: - No systemic clinical signs related to the administration of the test item were observed. - Cutaneous reactions (erythema) were noted from 24 h post-dose in all females and were totally reversible on Day 5 in females. Dryness was noted on Day 5 in all f

Gross pathology:

Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

None

Any other information on results incl. tables

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 of Hydrocarbons, terpene processing by-products batch 129958 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation (EC) N° 1272/2008.

Executive summary:

In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) were given a single dermal application of Hydrocarbons, terpene processing by-products batch 129958 at 2000 mg/kg bw. The test item was placed onto the intact skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema) were noted from 24 h post-dose in all females and were totally reversible on Day 5 in females. Dryness was noted on Day 5 in all females and was totally reversible on Day 8. Body weight evolution of the animals remained normal throughout the study. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The combined dermal LD50 of test item was considered to be higher than 2000 mg/kg bw in rats.

The acute dermal LD50 of Hydrocarbons, terpene processing by-products batch 129958 is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation (EC) N° 1272/2008.