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EC number: 617-779-3 | CAS number: 85940-94-9
Skin sensitisation
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- DESMODUR BL 3175
- IUPAC Name:
- DESMODUR BL 3175
- Details on test material:
- - Name of test material (as cited in study report): Polyisocyanate-resin, blocked Nr. 94831484
- Physical state: Clear yellowish liquid
- Analytical purity: 75%
- Composition of test material, percentage of components: HDI Trimer MEKO blocke din Solventnaphta 100
- Lot/batch No.: 2047
- Expiration date of the lot/batch: Not indicated
- Stability under test conditions: Stable for a least 4 hours in propylene glycol.
The sponsor is responsible for the completeness and GLP compliance of all test susbtance data.
- Storage condition of test material: At room temperature, dry and in the dark.
- Other: When necessary, the test substance was prepared in propylene glycol (w/w) prior to each treatment. No adjustement was made for specific
gravity of vehicle. The test substance was homogenised using a mechanical stirrer.
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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)
Challengeopen allclose all
- 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
Study design: in vivo (LLNA)
- Statistics:
- No data
Results and discussion
- 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.)
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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).
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