Registration Dossier
Registration Dossier
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EC number: 411-410-8 | CAS number: 118562-73-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Test according to OECD guideline 406 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-04-08 to 1993-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test according to OECD guideline 406 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990
- Remarks:
- Test according to OECD guideline 406 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD 406, May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test according to OECD guideline 406 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990
Test material
- Reference substance name:
- Hydroxyambran
- IUPAC Name:
- Hydroxyambran
- Test material form:
- solid: crystalline
- Details on test material:
- Hydroxyambran
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animals:
Species: Guinea pig
Strain: Pirbright white
Substrain: Bor: DHPW (SPF)
Source: Firma Winkelmann, Versuchtierzucht, Gartenstr. 27, W-4799 Borchen
Date of receipt March 24 and April 28, 1993 (range finding), March 17, 1993 (main test)
Acclimation period: 15 days (range finding), 30 days (main test)
Animal selection: random
Animal identification: with colored markings; cage labelled with sex, date of study initiation, project no.
Weight range at
study initiation: m: 418 – 500 g; f: 359 – 471 g
Husbandry:
Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type IV)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 22 +/- 3 °C
Relative humidity: 30 – 70 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-G (Alleindiät für Meerschweinchen)
Form: Pellets
Water: Administration: ad libitum
System: Makrolon drinking bottles
Quality: Drinking water as for human consumption
Quality control: half-yearly analyses and bacteriological tests
Bedding: Manufacturer: Rettenmaier & Söhne GmbH + C0., 7092 Ellwangen-Holzmühle
Name: „LIGNOCEL ¾ Fasern“
Production: from pure soft wood; dried, freed from dust and sterilized
Sterilization: 180 °C
Water binding capacity (% of dry weight): 276,5
Results and discussion
- Positive control results:
- The reaction to the positive control substance 2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (mild sensitizer) is tested periodically. The last test with an acceptable level of response to each of these substances was performed in April 1993.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Any other information on results incl. tables
Summary of skin reactions:
Concentration |
Reaction rate (%), 24 h |
Reaction rate (%), 48 h |
||
|
Test group |
Control group |
Test group |
Control group |
Challenge: 75 % |
40 |
15 |
40 |
30 |
Rechallenge: 50 % |
0 |
5 |
0 |
5 |
Rechallenge: 25 % |
0 |
0 |
0 |
0 |
Body weight development:
Animal no. |
Sex |
Initial BW (g) |
Final BW (g) |
1 |
m |
498 |
580 |
2 |
m |
499 |
634 |
3 |
m |
499 |
610 |
4 |
m |
499 |
644 |
5 |
m |
497 |
608 |
6 |
m |
500 |
716 |
7 |
m |
495 |
597 |
8 |
m |
481 |
638 |
9 |
m |
492 |
650 |
10 |
m |
457 |
608 |
11 |
f |
400 |
512 |
12 |
f |
431 |
543 |
13 |
f |
462 |
508 |
14 |
f |
433 |
584 |
15 |
f |
470 |
538 |
16 |
f |
426 |
520 |
17 |
f |
405 |
504 |
18 |
f |
451 |
515 |
19 |
f |
448 |
546 |
20 |
f |
401 |
516 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- “Hydroxyambran” may be classified as a “non sensitizer”.
- Executive summary:
The Skin Sensititzation of Hydroxyambran was determined according to the OECD Test Guideline 406 using the Guinea Pig Maximization Test after B. Magnusson and A.M. Kligman.
After an intradermal injection induction procedure using 2,5 % of the test article and a dermal induction procedure using the undiluted test article no animal showed an allergic response after dermal challenge using 50 % of the test article in corn oil.
Therefore “Hydroxyambran” may be classified as a “non sensitizer”.
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