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Administrative data

Description of key information

In a dermal sensitization study with DESMODUR BL 3175 in propylene glycol, performed according to the OECD 406 guideline, in compliance with GLP dermal reactions were observed in more than 30% of the animals tested for the three concentrations challenged. Thus DESMODUR BL 3175 is classified as sensitising to the skin according to the criteria of the Annex VI to the Directive 67/548/EC and to the criteria of the Annex I to the CLP Regulation N° (1272/2008).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-conducted study according to guideline, GLP, deviation: only 12 instead of 20 animals in the treatment group
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
only 12 animals used in the treatment group
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Study conducted in 1993, no OECD Guidelines were available for LLNA at this date (OECD 429 firstly adopted in 2002)
Species:
guinea pig
Strain:
other: Bor:DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: appr. 4-7 weeks
- Weight at study initiation: mean 320 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 7 days
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
100% for induction
50 and 25% for first challenge
12 and 6% for second challenge
25% for second challenge
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
100% for induction
50 and 25% for first challenge
12 and 6% for second challenge
25% for second challenge
No. of animals per dose:
12
Details on study design:
RANGE FINDING TESTS:
- concentrations of 12, 25, 50 and 100 % were tested
- occlusive treatment for 6 hours
- Evaluaton (hr after treatment): 24, 48 and 72 hours
- number of animals in the range finding test: 5/concentration
- result: no signs of irritation

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3, separated by 7 days each
- Exposure period: 6 h occusive
- Test groups: 12 animals
- Control group: 12 animals
- Concentrations: 100 %
- Evaluation: 24 hours after each induction
- Result: slight skin erythema (grade 0.) after second (3 animals) and third (5 animals) induction.

B. CHALLENGE EXPOSURE
- No. of exposures: 2 (first and second challenge), epicutaneous treatment
- Day(s) of challenge: first challenge started 2 weeks after 3rd induction treatment, second challenge 7 days later
- Exposure period: 6 hours occlusive for each challenge
- Concentrations: 50 and 25 % for first challenge, 12 and 6 % for second challenge
- Evaluation (hr after challenge): 24, 48 and 72 hours after start of challenge

Reliability of the test system is routinely confirmed.
Challenge controls:
yes: control group animals were treated in challenge experiments according to test group animals
Positive control substance(s):
not required
Statistics:
No data
Positive control results:
Routinely performed tests confirmed the sensitivity and reliability of the test system.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
4
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Group:
other: negative control group 24, 48 and 72 hours after challenge
Dose level:
50%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: other: negative control group 24, 48 and 72 hours after challenge. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
4
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
5
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 5.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
1st reading
Group:
other: negative control group 24, 48, and 72 hours after challenge
Dose level:
25%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: other: negative control group 24, 48, and 72 hours after challenge. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12%. No with. + reactions: 8.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 8.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
12%
No. with + reactions:
6
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12%. No with. + reactions: 6.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Group:
other: negative control group, 24, 48, and 72 hours after challenge
Dose level:
12%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. Group: other: negative control group, 24, 48, and 72 hours after challenge. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6%. No with. + reactions: 8.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6%. No with. + reactions: 8.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
6%
No. with + reactions:
4
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 12.0. Clinical observations: none.
Reading:
2nd reading
Group:
other: negative control group, 24, 48, and 72 hours after challenge
Dose level:
6%
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. Group: other: negative control group, 24, 48, and 72 hours after challenge. Dose level: 6%. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: none.
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

The first challenge with the 50% and 25% test item formulation led to skin effects (slight to moderate) in 4/12 animals and 5/12 of the test item group, respectively. The second challenge with a 12% and 6% test item formulation led to skin effects (slight to moderate erythema and/or scale formation) in 9/12 animals (in one animal erythema was recognized after 48 and 72 hours only). In none of the control animals signs of skin reactions were seen. In summary, under the conditions of the Buehler test and with respect to the evaluation criteria the test item exhibits a distinct skin-sensitization potential.

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the test conditions, DESMODUR BL 3175 is classified as sensitising to the skin according to the criteria of the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N°( 1272-2008).
Executive summary:

In a Buehler test, conducted according to the OECD 406 guideline in compliance with GLP, Desmodur BL 3175 was tested on 12 female Guinea pigs per group for its skin sensitizing properties . Concentrations of 100 (epicutaneous induction), 50 and 25% (first challenge) and 12 and 6% (second challenge) of the test material in propylene glycol were used.

Under the conditions, Desmodur BL 3175 was shown to exhibit a distinct skin sensitization potential.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-conducted guideline study, GLP with no deviations
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study conducted in 1995, no OECD Guidelines were available for LLNA at this date (OECD 429 firstly adopted in 2002)
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd, Basel
- Age at study initiation: 6 weeks
- Weight at study initiation: 274-421g
- Housing: 2 animals by metal cage with wire-mesh floors
- Diet (e.g. ad libitum): free access to standard guinea-pig diet including ascorbic acid (1600 mg/kg)
- Water (e.g. ad libitum): free access to tap water, diluted with decalcified water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
Fluctuations from these optimal conditions were noted, bt were considered not to have affected study integrity.
- Air changes (per hr): 15 airs changes per hour
- Photoperiod (hrs dark / hrs light): lighting was 12 hours artificial flurorescent light and 12 hours dark per day


IN-LIFE DATES: From: 08.23.1994 To: 09.23.1994
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
INDUCTION - EXPERIMENTAL ANIMALS
- Intradermal induction: 0.5% in propylene glycol (w/w)
- Epidermal induction: undiluted test substance: 100% (w/w)

INDUCTION - CONTROL ANIMALS
Intradermally injected as similar to described above for the experimental animals without the test substance.
Epidermally treated with a dry patch.

CHALLENGE
- Challenge: 50, 25 and 10% in propylene glycol (w/w)

Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
INDUCTION - EXPERIMENTAL ANIMALS
- Intradermal induction: 0.5% in propylene glycol (w/w)
- Epidermal induction: undiluted test substance: 100% (w/w)

INDUCTION - CONTROL ANIMALS
Intradermally injected as similar to described above for the experimental animals without the test substance.
Epidermally treated with a dry patch.

CHALLENGE
- Challenge: 50, 25 and 10% in propylene glycol (w/w)

No. of animals per dose:
Preliminary study: 5 females
Experimental group: 10 females
Control group: 5 females
Details on study design:
RANGE FINDING TESTS:


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 : intradermal and epidermal
- Exposure period: 48 hours for epidermal exposure
- Test groups:
- Control group:
- Site: in the clipped scapular region
- Frequency of applications: intradermal exposure on Day 1 and epidermal exposure on Day 8
- Duration:
- Concentrations: 0.5% in propylene glycol (w/w) for intradermal exposure and 100% of undiluted substance for epidermal exposure


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 48 hours
- Test groups:
- Control group:
- Site: on the clipped and shaved flank
- Concentrations: 50, 25 and 10% in propylene glycol (w/w)
- Evaluation (hr after challenge): 24 and 48 hours &fter removal of the dressings


OTHER:
In addition to the skin reactions the following data were recorded:
- Mortality/Viability/Toxicity : Twice daily
- Body weight: Prior to start and at termination of the study
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamidecaldehyde
Statistics:
No data
Positive control results:
The positive control experiment (most recent in July 1994) was carried out to check the sensitivity of the test system as used by NOTOX, in
accordance with the test method described in the report.
Concentrations selected for this study were:
- Intradermal induction: 5% solution in physiological saline (w/w)
- Epidermal induction: undiluted test substance: 100%
- Challenge: 10, 5, 2 and 0% solution in distilled water (w/w)

Taking into account the intensity if the skin reactions noted in the control animals, it was considered that positive reactions, indicative of sensitisation, were observed in all experimental animals in response to one or more of the test substance concentrations. These results lead to the maximum
sensitisation rate of 100%, which indicates that Alpha-Hexylcinnamidecaldehyde has extreme sensitising properties in this test applying the rating if
allergenicity described by Kligman A. M. (1996). (See table 7.4.1 a.)


Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% . No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% . No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% . No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 0.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 0.0.

PRELIMINARY STUDY (See Table 7.4.1 b.)

No signs of systemic toxicity were observed.

The test substance concentrations used in the main study were based on the findings in the preliminary study and in accordance with Magnusson and Kligman (1969).

The highest concentration inducing skin irritation used for induction is 100%

The non-irritant highest concentration is 50%.

MAIN STUDY - INDUCTION (See table 7.4.1 c.)

All experimental and control animals showed a marked area with necrosis and erythema around theses areas, 24 hours after the intradermal injections. Four experimental animals showed slight erythema after the 48 hours occluded epidermal induction exposure. The control animals showed no skin irritation.

MAIN STUDY - CHALLENGE

Control group: (See table 7.4.1 e.)

Two animals showed discrete or patchy erythema and scaliness in response to the 50% test substance and one of these two animals showed a similar skin reaction in response to the 25% concentration. No skin reactions were evident in response to the 10% concentration.

Exeprimental group: (See table 7.4.1 d.)

Nine, eight and seven animals of a total of nine experimental animals showed a skin reaction in response to 50%, 25% and 10% test substance concentrations, respectively. These reactions were characterised by redness (grade 1 and 2) and scaliness and in three animals eschar/crust formation (grade 4) in response to the 50% concentration.

TOXICITY Symptoms / MORTALITY

No mortality occured and no symptoms of systemic toxicity were observed in the animals of the main study during the study period.

However, one experimental animal (No.584) was killed in extremis on Day 14. One paw of this animal was jammed in the wire-mesh floor of the cage and had become severely injured.

BODY WEIGHTS

The average body weight gain of experimental and control animals was considered to be similar.

Table 7.4.1 a. Skin reactions to the challenges for positive control

 

Alpha-Hexylcinnamidecaldehyde

10%

5%

2%

0%

Number of experimental animals with skin reactions (scores varying 1-4)

10

10

10

0

Number of control animals with skin reactions (scores 1 only)

5

3

0

0

Number of positive reactions

6

5

10

0

Sensitisation rate (%)

60

50

100

0

Table 7.4.1 b.Scores observed from the challenge response in the preliminary test

Skin readings after bandage removal

 

 

24h

48h

Animal No.

Concentration % (w/w)

erythema

oedema

erythema

oedema

595

100

50

25

10

1

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

596

100

50

25

10

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

597

100

50

25

10

2

1

0

0

0

0

0

0

2

0a

0

0

0

0

0

0

598

100

50

25

10

1

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

a = this site showed fissuring of the skin

Table 7.4.1 c.Challenge readings for experimental group

Experimental group

 

 

 Day 24

Day 25

Sex

Animal number

Readings

Readings

 

 

50

25

10

0

50

25

10

0

Female

580

2

2

1

0

2s

1s

1s

0

 

581

2

1

1

0

1s

1

1

0

 

582

1

1

0

0

2s

1s

0s

0

 

583

4

2

1

0

4ks

2s

2s

0

 

584

-

-

-

-

-

-

-

-b

 

585

4k

2

2

0

4ks

1s

1s

0

 

586

1

0

0

0

1s

0

0

0

 

587

4k

1

2

0

4k

1

1

0

 

588

1

1

1

0

1s

1

1

0

 

589

1

1

1

0

1

1

1

0

s = this site also showed scaliness

k = this site also showedeschar/crust formation

b = this animal was killed in extremis on Day 14

Table 7.4.1d.Challenge readings for control group

Control group

 

 

 Day 24

Day 25

Sex

Animal number

Readings

Readings

 

 

50

25

10

0

50

25

10

0

Female

590

0

0

0

0

0

0

0

0

 

591

1

0

0

0

1s

0

0

0

 

592

0

0

0

0

0

0

0

0

 

593

1

1

0

0

1s

0

0

0

 

594

0

0

0

0

0

0

0

0

s = this site also showed scaliness

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the test conditions, DESMODUR BL 3175 is classified as sensitizing for the skin according to the criteria of the Annex VI to the Directive
67/548/EEC and to the criteria of the Annex I to the CLP Regulation (EC) N°( 1272-2008).
Executive summary:

In a sensitising study, performed according to the OECD guideline N°406 ( Maximization test of Magnusson and Kligman) in compliance with GLP, 10 females albino guinea-pig per doses were exposed to DESMODUR BL 3175 in a preliminary test in order to select the concentrations for the main study. The highest dose inducing skin irritation is 100% and the non-irritant highest dose is 50%, respectively used for induction and challenge in the main study.

Nine, eight and seven animals showed a skin reaction in response to the 50, 25 and 10% test substance concentrations in the main study, respectively.

Therefore, DEMSODUR BL 3175 is classified as a sensitising to the skin according to the criteria of the Annex VII to the Directive

67/548/EEC and to the criteria of the Annex I to the CLP Regulation (EC) N°( 1272-2008).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a dermal sensitization study , performed according to the OECD 406 guideline (Maximization test of Magnusson and Kligman) (Daamen P.A.M., 1995) in compliance with GLP, 10 female guinea-pigs per dose were exposed to DESMODUR BL 3175 in propylene glycol.A preliminary test has been performed in order to select the concentrations for the main study. The highest concentration inducing skin irritation is 100% and the non-irritant highest concentrations is 50%. Therefore, the concentration used for induction is 100% and 50, 25 and 10% respectively for induction and challenges.

Nine, eight and seven animals showed skin reaction in response to the 50, 25 and 10% concentrations in the main study, respectively.


Migrated from Short description of key information:
In a dermal sensitization study with DESMODUR BL 3175 in propylene glycol, performed according to the OECD 406 guideline, in compliance with GLP
dermal reactions were observed in more than 30% of the animals tested for the three concentrations challenged.
Thus DESMODUR BL 3175 is classified as sensitising to the skin according to the criteria of the Annex VI to the Directive 67/548/EC and to the
criteria of the Annex I to the CLP Regulation N° (1272/2008).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data

Justification for classification or non-classification

As dermal reactions were seen during the three challenges in more than 30% of the animals (9/10 for 50%, 8/10 for 25 and 7/10 for 10% respectively test item formulation), in a dermal sensitization study performed according to guideline OECD 406 in compliance with GLP, DESMODUR BL 3175 (75% HDI Trimer MEKO blocked in 25% of solvent naphta 100) is classified as sensitising to the skin according to the criteria of the Annex VI to the Directive 67/548/EC and to the criteria of the Annex I to the CLP Regulation N° (1272/2008).

According to an expert judgment, HDI Trimer MEKO blocked is classified as a sensitiser to the skin by default as the solvent is not sensitising and as the preparation contains about 75% of test substance.