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Description of key information

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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study without deviations
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1987
Deviations:
yes
Remarks:
Evaluation 24, 48 and 72 hours after challenge
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Harlan-Winkelmann, Borchen, Germany
- Age at study initiation: healthy young adults
- Weight at study initiation: 436 - 527 g
- Housing: conventional, max. 5 animals per cage (Makrolon Type IV)
- Diet: Ssniff G 4 ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 -70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12


Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Conc. 50 % (w/w) in maize oil (MEH 56) (induction and challenge)
No. of animals per dose:
Test group: 20
Controls: 10
Details on study design:
Application volume: 0,4 mL

RANGE FINDING TESTS: 2,5; 25; 50% (w/w) in maize oil (MEH 56) and 100% (w/w)


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Induction on days: 0, 7, 14
- Concentration: 50% (w/w) in maize oil (MEH 56)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Challenge on day: 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentration: 50% (w/w) in maize oil (MEH 56)
- Evaluation (hr after challenge): 24, 48 and 72


Positive control substance(s):
yes
Remarks:
1-Chlor-2,4-dinitrobenzol (HS-92/CDNB-1; 25.04.1993 - 27.05.1993)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a GLP-guideline study according to OECD 406 the sensitation potential to guinea pig skin of 1-chlorobutane was examined (Buehler Test). 20 female Dunkin Hartley guinea pigs were induced with 50% n-butyl chloride in maize oil MEH 56 (w/w) by epidermal application on days 0, 7 and 14 for 6 hours. 10 guinea pigs served as control. 24 hours after the third induction exposure 6 animals exhibited slight to precisely defined skin irritations and another animal developed moderate edema and erythema. Following a rest period of 14 days the animals were exposed to the challenge dose (50% 1-chlorobutane in maize oil (w/w)). 24, 48 and 72 hours after challenge none of the animals showed changes at the exposed skin areas. Systemic toxic effects could not be detected. The general condition and body weight development of the test animals were not affected.


Migrated from Short description of key information:
-guinea pig (Buehler test): not skin sensitising (93-0264-DGT)

Justification for selection of skin sensitisation endpoint:
One study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

The data is conclusive but not sufficient for classification according to DSD (67/548/EEC) and CLP (1272/2008/EC).

Respiratory sensitisation:

CLP: Classification is not possible due to data lacking.