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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 January 1992 to 22 February 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Justification for type of information:
Study conducted before the requirement of LLNA study was implemented.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An OECD 406 test was already conducted so it was considered unethical to run an LLNA test for animal welfare reasons.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 6 to 7 weeks on arrival.
- Weight at study initiation: 301 to 370 g on arrival.
- Housing: The guinea-pigs were housed in groups of ten in suspended metal cages with wire mesh floors.
- Diet (e.g. ad libitum): A vitamin C enriched guinea-pig diet was provided ad libitum. Hay was given weekly.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 12 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 °C.
- Humidity (%): 30 to 70 % relative humidity.
- Air changes (per hr): Air exchange was maintained at approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 to 1900 hours) in each 24 hour period.

IN-LIFE DATES: From: 28 January 1992 To: 22 February 1992
Route:
other: Intradermal and topical
Vehicle:
other: Alembicol D
Concentration / amount:
Induction intradermal injection - 7.5 %
Induction topical application - as supplied
Topical challenge - as supplied and 50 % v/v
Route:
other: topical
Vehicle:
other: Alembicol D
Concentration / amount:
Induction intradermal injection - 7.5 %
Induction topical application - as supplied
Topical challenge - as supplied and 50 % v/v
No. of animals per dose:
20 animals were used for the test group.
Details on study design:
RANGE FINDING TESTS: Yes. Animals were exposed to the test material in the intradermal induction at concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0 % v/v. For the topical induction, the animals were exposed to the test material at concentrations of 50, 60 and 75 % v/v and as supplied.

MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INJECTIONS
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 2 x 4 cm area within the clipped area as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. Test material 7.5 % v/v in Alembicol D.
3. Test material 7.5 % v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
TOPICAL APPLICATION
The preliminary investigation indicated that the maximum practical concentration of the test material for topical application (as supplied) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.2 mL per site of 10 % w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later, a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 mL of the test material, as supplied. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.

In the induction phase, the control animals were treated similarly with the exception that the test material was omitted.

B. CHALLENGE EXPOSURE
The control and test animals were challenged topically two weeks after the topical induction application using the test material as supplied and 50 % v/v in Alembicol D.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 20 x 20 mm patch of Whatman No. 3 paper was saturated with approximately 0.2 mL of the test material as supplied and applied to an anterior site on the flank. The test material 50 % v/v in Alembicol D was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek".
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches.

OBSERVATIONS
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Bodyweight: The bodyweight of each guinea-pig on the main study was recorded on Day 1 (day of intradermal injections) and on the last day of observation of dermal responses in the challenge.
- Dermal responses: The dermal reactions resulting from intradermal injection and topical application on the preliminary study, and topical application at the challenge were assessed using the following numerical system.

Erythema and eschar formation:
No erythema 0
Slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:
No oedema 0
Slight oedema 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Any other lesion not covered by this scoring system was described.

INTERPRETATION OF RESULTS
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in control animals, the result for that test animal was classified as inconclusive.
A test animal was considered to show no evidence of delayed contact hypersensitivity if the dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group.
Positive control substance(s):
yes
Remarks:
Formalin
Positive control results:
The sensitivity of the guinea-pig strain used at the testing facility was checked periodically with formalin. Formalin was shown to cause sensitisation and therefore demonstrate the suitability of the test system.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
Test material as supplied and 50 % v/v in Alembicol D
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
Test material as supplied and 50 % v/v in Alembicol D
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
Test material as supplied and 50 % v/v in Alembicol D
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
Formalin
No. with + reactions:
20
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
Formalin
No. with + reactions:
20
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
positive control
Dose level:
Formalin
No. with + reactions:
20
Total no. in group:
20

Clinical Signs

No signs of ill health or toxicity were recorded.

 

Bodyweight

Bodyweight increases were recorded for all guinea-pigs over the period of the study.

 

Induction

- Intradermal injections: Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Irritation was seen in test animals at sites receiving the test material 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 the test material 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.

Table 1 Dermal Reactions Observed After Induction

Site

Intradermal injection

Topical Application

Test Animals

Control Animals

Test Animals

Control Animals

1

Necrosis

Necrosis

 

Slight erythema

Very Slight erythema

2

Irritation

Slight irritation

3

Necrosis

Necrosis

 

Table 2 Dermal Reactions Observed After the Challenge Application in Control Animals

Guinea-Pig Number

 

Score

Guinea-Pig Number

 

Score

24 Hours

48 Hours

72 Hours

24 Hours

48 Hours

72 Hours

A

P

A

P

A

P

A

P

A

P

A

P

200

E

O

0

0

0

0

0

0

0

0

0

0

0

0

210

E

O

0

0

0

0

0

0

0

0

0

0

0

0

201

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

211

E

O

0

0

0

0

0

0

0

0

0

0

0

0

202

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

212

E

O

0

0

0

0

0

0

0

0

0

0

0

0

203

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

213

E

O

L1

0

0

0

0

0

0

0

0

0

0

0

204

E

O

0

0

0

0

0

0

0

0

0

0

0

0

214

E

O

0

0

0

0

0

0

0

0

0

0

0

0

205

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

215

E

O

0

0

0

0

0

0

0

0

0

0

0

0

206

E

O

0

0

0

0

0

0

0

0

0

0

0

0

216

E

O

0

0

0

0

0

0

0

0

0

0

0

0

207

E

O

L1*

0

0

0

L1*

0

0

0

0*

0

0

0

217

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

208

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

218

E

O

0

0

0

0

0

0

0

0

0

0

0

0

209

E

O

0

0

0

0

0

0

0

0

0

0

0

0

219

E

O

0

0

0

0

0

0

0

0

0

0

0

0

E = Erythema

O = Oedema

L = Localised dermal reaction restricted to a small area of the challenge site.

*= Dryness and sloughing of the epidermis.

A = Anterior site, exposed to the test material as supplied.

P = Posterior site, exposed to the test material 50 % v/v in Alembicol D

 

Table 3 Dermal Reactions Observed After the Challenge Application in Test Animals

Guinea-Pig Number

 

Score

Result

Guinea-Pig Number

 

 

Score

Result

24 Hours

48 Hours

72 Hours

24 Hours

48 Hours

72 Hours

A

P

A

P

A

P

A

P

A

P

A

P

220

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

-

230

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

221

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

231

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

222

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

232

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

223

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

233

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

224

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

234

E

O

0*

0

0

0

0*

0

0

0

0*

0

0

0

-

225

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

235

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

226

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

-

236

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

227

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

237

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

228

E

O

0

0

0

0

0*

0

0

0

0*

0

0

0

-

238

E

O

L1

0

0

0

0*

0

0

0

0*

0

0

0

-

229

E

O

L1*

0

0

0

0*

0

0*

0

0*

0

0

0

-

239

E

O

0

0

0

0

0

0

0

0

0

0

0

0

-

E = Erythema

O = Oedema

L = Localised dermal reaction restricted to a small area of the challenge site.

*= Dryness and sloughing of the epidermis.

A = Anterior site, exposed to the test material as supplied.

P = Posterior site, exposed to the test material 50 % v/v in Alembicol D

Interpretation of results:
not sensitising
Conclusions:
Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.
Executive summary:

The potential of the test substance to cause skin sensitisation (delayed contact hypersensitivity) was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. Twenty albino Dunkin-Hartley guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 7.5 % v/v in Alembicol D for the intradermal application and undiluted test material for the topical application. Formalin was used as the positive control substance. In the challenge application, the animals were exposed to the test material as supplied and 50 % v/v in Alembicol D. No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals. Under the conditions of this study, the test material did not produce evidence of skin sensitisation (Parcell, 1992).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 February 1993 to 5 March 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. Study read-across from supporting substance.
Justification for type of information:
Study conducted before the requirement of LLNA study was implemented.
Qualifier:
according to guideline
Guideline:
other: 40 CFR 158, Guideline #81-6
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
10 animals were treated with the test material.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
An OECD 406 test was already conducted so it was considered unethical to run an LLNA test for animal welfare reasons.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 357 to 446 g.
- Age at study initiation: Young adult.
- Housing: The animals were gang-caged in suspended stainless steel cages with mesh floors.
- Diet (e.g. ad libitum): ad-libitum.
- Water (e.g. ad libitum): tap water supplied by automatic water system.
- Acclimation period: 5 or 14 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23 °C (67 to 73 F)

IN-LIFE DATES: From: 20 or 29 January 1993 To: 5 March 1993
Route:
other: topical
Vehicle:
water
Remarks:
The test material was a dry powder. It was applied in water in order to enhance skin contact.
Concentration / amount:
95 % w/w in water
Route:
other: topical
Vehicle:
water
Remarks:
The test material was a dry powder. It was applied in water in order to enhance skin contact.
Concentration / amount:
95 % w/w in water
No. of animals per dose:
Test group: 10 animals
Naive control group: 5 animals
Positive control group: 10 animals
Naive control for positive control group: 5 animals
Details on study design:
PRELIMINARY IRRITATION TESTING
Prior to the period of induction, the highest non-irritating concentration (HNIC) and the minimally irritating concentration (MIC) of test material were determined. The dorsal thoracolumbar region of 4 guinea pigs was rid of hair by clipping. This area was divided into 4 test sites (2 sites on each side of the midline) on each animal. The test material was diluted with distilled water to yield concentrations of 95, 75, 50 and 25 %. The test solutions were applied to the pre-assigned, delineated test sites on each animal. Each site was covered with a Hilltop chamber which was secured in place with hypoallergenic adhesive tape. After 6 hours of exposure the chambers were removed. Twenty-four hours after application, each site was evaluated for local reactions (erythema). From these results the HNIC and the MIC were established. These were respectively defined as the highest concentration that produced responses in 4 guinea pigs no more severe than 2 scores of 0.5 and 2 scores of zero and the lowest concentrations that produced mild to moderate irritation. The MIC was used for Induction and the HNIC was used for the challenge.
The MIC of the test material was a 95 % w/w mixture in distilled water.

INDUCTION AND CHALLENGE
Twenty guinea pigs were divided into subgroups and placed in stainless steel gang cages, 2 to 3 animals per cage. Ten animals were assigned to the test group and ten were assigned to the positive control group. Prior to each application, the hair was removed from the dorsal thoracolumbar region of each guinea pig by clipping. 0.4 mL of the test and positive control materials at their respective MICs were placed onto an occlusive 25 mm Hilltop Chamber. One dosing chamber was placed over the left scapular/thoracic region of each guinea pig. The chambers were secured in place with hypoallergenic adhesive tape. They were removed after six hours of exposure and each site was wiped clean of residual material. Twenty-four and 48 hours after each induction application, readings were made of local reactions (erythema). This process was repeated on the same day once a week until a total of three dose applications had been made. Fourteen days after the third induction dose, a challenge dose was applied to a naive site on the right side of each guinea pig as described above. The HNIC was used for the challenge phase. These sites were evaluated for a sensitisation response (erythema) at 24 and 48 hours after the challenge application.

SCORING FOR IRRITATION
0 - no reaction
0.5 - very faint erythema, usually non-confluent
1 - faint erythema usually confluent
2 - moderate erythema
3 - strong erythema with or without oedema
Challenge controls:
In addition to the test and positive control animals, ten guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the test or positive material at the HNIC at the time of challenge only. These constituted the "naive" group.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (DNCB) was used as positive control; the HNIC was a 0.03 % w/w solution in acetone. The MIC was a 0.08 % w/w solution in aqueous ethanol.
Positive control results:
INDUCTION PHASE
Positive Control Animals (0.08 % DNCB in 80 % Aqueous Ethanol)
All positive control sites exhibited very slight to severe erythema during the induction phase. The incidence and severity of irritation increased with each successive application. Following the second and third inductions, eschar was noted at several sites.

CHALLENGE PHASE
Positive Control Animals (0.03 % DNCB in Acetone)
Twenty-four hours after challenge, 8 of 10 positive control sites exhibited signs of a sensitisation response including faint to moderate erythema. These indications persisted at all sites through 48 hours.
Positive Naive Control Animals (0.03 % DNCB in Acetone)
Very faint erythema was noted at 3 of 5 positive naive control sites 24 hours after challenge. Irritation cleared from one site by 48 hours.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
95 % w/w
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
95 % w/w
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.03% DNCB
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.03% DNCB
No. with + reactions:
8
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
3
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
2
Total no. in group:
10

All guinea pigs appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. All animals gained weight.

 

Table 1 Skin Irritation Scores - Induction Phase

Test Material

Positive Control

Induction No.

1

2

3

Induction No.

1

2

3

Conc. (%)

95

95

95

Conc. (%)

0.08

0.08

0.08

Amount Applied (g)

0.4

0.4

0.4

Amount Applied (mL)

0.4

0.4

0.4

Hours After Dose

24

48

24

48

24

48

Hours After Dose

24

48

24

48

24

48

Animal No.

 

Animal No.

 

7733

0

0

0

0

0

0

7763

0.5

0

3

3

3*

3*

7734

0

0

0

0

0

0

7764

1

1

2

2

3

2

7735

0

0

0

0

0

0

7765

1

0.5

3

3

3

3

7736

0

0

0

0

0

0

7766

1

1

3

3

3

3*

7737

0

0

0

0

0

0

7767

1

1

2

2

2

2

7738

0

0

0

0

0

0

7768

1

0.5

3*

3*

3*

3*

7739

0

0

0

0

0

0

7769

1

1

3

3

3

3*

7740

0

0

0

0

0

0

7770

1

1

3*

3*

3*

3*

7741

0

0

0

0

0

0

7771

1

0.5

3

3

3*

3*

7742

0

0

0

0

0

0

7772

1

1

2

2

3

3*

*Eschar

 

Table 2 Skin Irritation Scores - Challenge Phase

Animal No.

Test Material

Animal No.

Positive Control

24 Hours

48 Hours

24 Hours

48 Hours

Test Animals

 

Test Animals

 

7733

0

0

7763

0.5

0

7734

0

0

7764

1

1

7735

0

0

7765

2

2

7736

0

0

7766

1

1

7737

0

0

7767

2

2

7738

0

0

7768

1

1

7739

0

0

7769

1

1

7740

0

0

7770

0.5

0

7741

0

0

7771

1

1

7742

0

0

7772

1

1

Naïve Control Animals

 

Naïve Control Animals

 

7743

0

0

7773

0

0

7744

0

0

7774

0.5

0

7745

0

0

7775

0.5

0.5

7746

0

0

7776

0.5

0.5

7747

0

0

7777

0

0

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material was determined not to be a sensitiser and therefore requires no classification in accordance with EU criteria.
Executive summary:

The potential of the test substance to be a contact sensitiser was investigated in a study conducted in accordance with the standardised guideline 40 CFR 158, Guideline 81-6, broadly equivalent to the standardised guideline OECD 406, under GLP conditions. A 3 week induction period was initiated during which 10 young adult Hartley guinea pigs were treated with the test substance at 95% and 10 positive control animals were treated with Dinitrochlorobenzene (DNCB) at 0.08 % in 80 % aqueous ethanol. During the induction period the animals were dosed once each week for three weeks. Fourteen days after the third induction a challenge dose was applied to the test and positive controls to a naive site on each group of guinea pigs (95% test substance and 0.08% DNCB, respectively). Approximately 24 and 48 hours later the animals were scored for a sensitisation response (erythema). Two naive control groups were maintained under the same environmental conditions and treated with the test or control material at challenge only. No irritation was noted in the test animals at either the induction or challenge phase. Under the conditions of this study the test material was determined not to be a sensitiser (Shapiro, 1993).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Distilled tall oil:

The potential of the test substance to cause skin sensitisation (delayed contact hypersensitivity) was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. Twenty albino Dunkin-Hartley guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 7.5 % v/v in Alembicol D for the intradermal application and undiluted test material for the topical application. Formalin was used as the positive control substance. In the challenge application, the animals were exposed to the test material as supplied and 50 % v/v in Alembicol D. No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals. Under the conditions of this study, the test material did not produce evidence of skin sensitisation (Parcell, 1992).

Potassium carbonate:

The potential of the test substance to be a contact sensitiser was investigated in a study conducted in accordance with the standardised guideline 40 CFR 158, Guideline 81-6, broadly equivalent to the standardised guideline OECD 406, under GLP conditions. A 3 week induction period was initiated during which 10 young adult Hartley guinea pigs were treated with the test substance at 95% and 10 positive control animals were treated with Dinitrochlorobenzene (DNCB) at 0.08 % in 80 % aqueous ethanol. During the induction period the animals were dosed once each week for three weeks. Fourteen days after the third induction a challenge dose was applied to the test and positive controls to a naive site on each group of guinea pigs (95% test substance and 0.08% DNCB, respectively). Approximately 24 and 48 hours later the animals were scored for a sensitisation response (erythema). Two naive control groups were maintained under the same environmental conditions and treated with the test or control material at challenge only. No irritation was noted in the test animals at either the induction or challenge phase. Under the conditions of this study the test material was determined not to be a sensitiser (Shapiro, 1993).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of an in vivo guinea pig maximisation study with the read-across substance distilled tall oil and a skin sensitisation study with potassium carbonate according to the Buehler protocol, the test substance does not warrant classification for skin sensitisation according to EU CLP (EC) No. 1272/2008 criteria.

Moreover, the composition of distilled tall oil closely matches that of Tall oil, potassium salt in terms of the distribution of fatty acids. It is likely that the skin sensitiser components of the crude tall oil are removed during the refining process.