Registration Dossier

Administrative data

Description of key information

Distilled Tall Oil was not sensitising to skin in a guinea pig maximisation test carried out in accordance with OECD Test Guideline 406 and in compliance with GLP (Huntingdon, 1992a).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992/01/28-1992/02/22
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Scientifically valid and acceptable OECD Guideline 406 guinea pig maximisation test.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: D.Hall, Newchurch, Staffordshire, England.

- Age at study initiation: 6-7 weeks

- Weight at study initiation: 301-370g

- Housing: The animals were housed in groups of ten in suspended metal cages with wire mesh floors.

- Diet: A vitamin C enriched quinea-pig diet FD1, ad libitum

- Water: ad libitum

- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): ca/ 21

- Humidity (%): 30-70

- Air changes (per hr): ca. 15

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

Route:
intradermal
Vehicle:
other: Alembicol D
Concentration / amount:
Induction injection 1. FCA diluted with an equal volume of water for irrigation.
Induction injection 2. Bevacid 25/30, 7.5% v/v in Alembicol D
Induction injection 3. Bevacid 25/30, 7.5% v/v in a 50:50 mixture of FCA and Alembicol D.
Topical challenge - As supplied and 50% v/v in Alembicol D.
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
Induction injection 1. FCA diluted with an equal volume of water for irrigation.
Induction injection 2. Bevacid 25/30, 7.5% v/v in Alembicol D
Induction injection 3. Bevacid 25/30, 7.5% v/v in a 50:50 mixture of FCA and Alembicol D.
Topical challenge - As supplied and 50% v/v in Alembicol D.
No. of animals per dose:
6 animals were used for the preliminary investigations, 20 animals in the control group and 20 as test animals.
Details on study design:
RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigates to identify where possible a) concentrations of the test substance that will produce irritation suitable for the induction phase of the main study and b) a maximum non-irritant concentration by the topical route of administration for the challenge phase. Based on the results of the preliminary investigations, the following concentrations of the test substance were selsected;
Induction intradermal injection - 7.5% in Alembicol D
Induction topical application - As supplied. This was the maximum concentration and did not give rise to irritating effects.
Topical challenge - As supplied and 50% v/v in Alembicol D. From preliminary investigations as supplied was the maximum concentration and did not give rise to irritating effects.


MAIN STUDY

A. INDUCTION EXPOSURE

- No. of exposures: 2. With treatment with 10% w/w sodium lauryl sulphate in petrolatum in between the initial induction injection and the final topical application (which was with a patch saturated in Bevacid 25/30 as supplied.)

- Test groups: Bevacid 25/30 in Alembicol/FCA

- Control group: The control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.

- Site: Dorsal skin on the scapular region

- Frequency of applications: Day 1 (injection), Day 6 (pre-treatment with sodium lauryl sulphate in petrolatum) followed by 24 hours later by a saturated patch firmly secured by elastic adhesive bandage, left in place for 48 hours.

- Duration: 0-14 day




B. CHALLENGE EXPOSURE

- No. of exposures: 1

- Day(s) of challenge: Day 14

- Exposure period: 24 hours

- Test groups: Bevacid 25/30, as supplied and 50% v/v in Alembicol D

- Control group: Same as test animals but without test substance.

- Site: anterior site on the flank

- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the patches.


Challenge controls:
20 animals were designated as challenge controls. They were challenged topically two weeks after the topical induction application using Bevacid 25/30, as supplied and 50% v/v in Alembicol D.
Positive control substance(s):
yes
Remarks:
formalin
Positive control results:
Historical data for the positive control (formalin) confirmed the suitability of the test system.
Key result
Hours after challenge:
48
Group:
negative control
Dose level:
Alembicol D
Total no. in group:
20
Remarks on result:
other: slight irritation was observed in control animals receiving Alembicol D
Key result
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 ml of Bevacid 25/30
Total no. in group:
20
Clinical observations:
The dermal responses seen in the test animals were similar to those of the controls
Remarks on result:
no indication of skin sensitisation
Key result
Group:
positive control
Dose level:
Formalin
Remarks on result:
other: Historical data for the positive control (formalin) confirmed the suitability of the test system.

Clinical signs: No signs of ill health or toxicity were recorded.

Induction:

Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Irritation was seen in test animals at sites receiving Bevacid 25/30, 7.5% v/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D. Topical application: Slight erythema was observed in test animals following topical application with Bevacid 25/30, as supplied. Very slight erythema was seen in the control guinea-pigs.

Challenge:

The dermal responses seen in the test animals were similar to those of the controls.

Interpretation of results:
other: Not sensitising
Conclusions:
The test substance was found to be not sensitising in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Only one skin sensitisation study is available for Distilled Tall Oil. This is a reliable guideline study, according to OECD Test Guideline 406 and in compliance with GLP (Huntingdon, 1992a). No positive skin reactions were observed in any test animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the criteria set out in Regulation 1272/2008 Distilled Tall Oil is not classified as a skin sensitiser on the basis of a reliable guinea pig maximisation test that was carried out in accordance with OECD Test Guideline 406 and in compliance with GLP. There was no evidence of sensitisation in 20 test animals.