[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 12, 2011 to July 26, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to the OECD 402 Guideline, with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines 2000 (Japanese Ministry of Agriculture, Forestry and Fisheries)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Molecular formula:

not applicable, UVCB

IUPAC Name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Details on test material:

- Physical state: Red-brownish liquid.
- Analytical purity: UVCB
- Expiration date of the lot/batch: 11 May 2013
- Stability under storage conditions: Stable.
- Storage condition of test material: At room temperature in the dark.
- Other:
Density: 0.95 g/cm3 (25°C).
pH: 8-10 at concentration of 5%.

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, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: From 279 g to 294 g (males) and from 187 g to 202 g (females). Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC.
- Humidity (%): 40-70%.
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From January 12, 2012 to January 26, 2012.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25 cm2 in males; approx. 18 cm2 in females.
- % coverage: approx. 10% of the total body surface.
- Type of wrap if used: dressing consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 24 h.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 mL/kg) bw.
- Concentration (if solution): Concentration in vehicle was 200 mg/mL.
- Constant volume or concentration used: yes.

VEHICLE
- Amount(s) applied (volume or weight with unit): 8.39 g/kg.

Duration of exposure:

24h

Doses:

2000 mg/kg (10 mL/kg) bw.

No. of animals per sex per dose:

5 animals.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days.
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights Days: 1 (pre-administration), 8 and 15.
Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes.
- Other examinations performed:
Clinical signs:
The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1)

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture, chromodacryorrhoea, piloerection and/or ptosis were noted in all animals on Days 1 and/or 2. Brown staining and/or scales were seen in the treated skin-area among the animals between Days 1 and Day 11. Scales and/or scabs were noted on th

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of the test substance in Wistar rats was determinated to be greaeter than 2000 mg/kg body weight.

Executive summary:

Assessment of acute dermal toxicity with Condensation products of cyclopentanone and pentaldehyde, fractionation pitch in the rat was determinated according to the OECD 402 Guideline, with GLP.

The dermal LD₅₀ value of the test substance in Wistar rats was determinated to be greaeter than 2000 mg/kg body weight.

Based on these results, Condensation products of cyclopentanone and pentaldehyde, fractionation pitch does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.