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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2005/09/26-2005/10/07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP using a related test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TALL OIL PITCH

- Physical state: Dark liquid

- Expiration date of the lot/batch: not stated

- Storage condition of test material: 10C-25C, in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.

- Age at study initiation: not reported

- Weight at study initiation: 1.8, 2.2 and 2.6kg

- Fasting period before study: no mention

- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79cm x 59cm bottom area, 38cm height.

- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum

- Water: Tap water from an automatic watering system, ad libitum

- Acclimation period: 5 days for one rabbit, 12 days for the other two.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): average of 19.6C

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin surrounding test area
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 ml

- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal.
Number of animals:
3F
Details on study design:
TEST SITE

- Area of exposure: dorsal thoracal region, clipped free of hair

- coverage: 2.5 x 2.5 cm

- Type of wrap if used: gauze patch held in place by fixing them marginally with non irritating tapes.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The tapes with the patches and the collars were removed, residual test substance was wiped off using wet cellulose tissue.

- Time after start of exposure: 4 hours



SCORING SYSTEM: According to OECD.

Results and discussion

In vivo

Irritant / corrosive response data:
All calculated mean scores were 0 for erythema/eschar and oedema at 24, 48 and 72 hours.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period.
There was a small increase in body weight for each of the animals. Animal 1: 1.8kg to 2.2kg, Animal 2: 2.6kg to 2.7kg, Animal 3: 2.2kg to 2.3 kg.
Residual test substance was noted on the exposed skin areas, resp. on the growing hair until 72h p.a.

Any other information on results incl. tables

There were no mortalities during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritant in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.