Registration Dossier

Administrative data

Description of key information

The key study (Murmann, P 1993) examined the potential of HAB to cause sensitization to skin. A preliminary dermal irritation test was done to determine the appropriate concentration of test substance to be used. Concentrations of 2.5, 25, and 50% test substance were tried. At the 50% concentration, slight dermal irritation (erythema score of 1) was seen. However, this level of irritation was also seen in the control area for this animal. The concentration for the induction and challenge phases was therefore 50%. A group of 10 female guinea pigs were exposed to a concentration of 50% of test substance. Ten female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. Fourteen days later, the animals were challenged by dermal application. Mild erythema (erythema score of 1) was seen in two animals in the test group during induction phase 1 at the 6 hr reading. During induction phase 2, all animals in the test group showed erythema (maximum score of 2) at the 6 hr reading only. At the third induction phase, all animals in the treatment group also showed erythema (maximum score of 2) and 8 animals showed edema (maximum score of 1) at the 6 hr reading. At the 24 hr reading, 2 animals still showed erythema (score of 1) and edema (score of 1). In the control group, all animals showed erythema (score of 1) at the 6 hr reading after induction phase 2. No other signs of irritation were seen in the control group. No signs of irritation were seen in either the control group or treatment group at any of the challenge readings. No signs of irritation were seen in any animals during the challenge phase. Therefore, HAB is not sensitising to skin.

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:
Nov. 3, 1992-Dec. 2, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from LLNA method not available; study not required based on availability of more definitive in vivo data, study was performed before REACH inforcement.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelman
- Age at study initiation: young adult
- Housing: 5 animals per cage, identified by skin markings
- Diet (e.g. ad libitum): Ssniff G4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Nov. 3, 1992 To: Dec. 10, 1992
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
50%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
50%
No. of animals per dose:
10
Details on study design:
In the induction phase, female guinea pigs (10 guinea pigs per test concentration) were given intradermal injections of the test substance to the shoulder region. This was followed one week later with percutaneous induction, in which the animals were exposed to about 0.4 g of the test substance by applying soaked 2 x 2 cm filter paper to the skin of the same shoulders previously injected, and held in place with an occlusive dressing for 48 hours. In the challenge phase, the first challenge occurred about 14 days after the percutaneous application, and the second challenge occurred one week later. In this phase, the test material was applied using soaked 2 x 2 cm filter paper strips held in place for 24 hours with an occlusive dressing. Observations of skin reactions were made throughout the study and scored.

Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
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%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
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%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other:
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Remarks:
A postive control was not conducted with every assay. Instead the sensitivity of the test system was checked at regular intervals with standard allergens, e.g. 1-chloro-2,4-dinitrobenzene.

Mild erythema (erythema score of 1) was seen in two animals in the test group during induction phase 1 at the 6 hr reading. During induction phase 2, all animals in the test group showed erythema (maximum score of 2) at the 6 hr reading only. At the third induction phase, all animals in the treatment group also showed erythema (maximum score of 2) and 8 animals showed edema (maximum score of 1) at the 6 hr reading. At the 24 hr reading, 2 animals still showed erythema (score of 1) and edema (score of 1). In the control group, all animals showed erythema (score of 1) at the 6 hr reading after induction phase 2. No other signs of irritation were seen in the control group. No signs of irritation were seen in either the control group or treatment group at any of the challenge readings.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not sensitising to skin.
Executive summary:

This study examined the potential of the test substance to cause sensitization to skin. A group of 10 female guinea pigs were exposed to a concentration of 50% of test substance. 10 female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. 14 days later, the animals were challenged by dermal application. No signs of irritation were seen in any animals during the challenge phase. The test substance is not sensitising to skin.

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

HAB is not a skin sensitiser based on GLP laboratory studies.


Justification for selection of skin sensitisation endpoint:
Key GLP guideline study reports experimental data

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Inhalation is not a relevant route of exposure.

Justification for selection of respiratory sensitisation endpoint:
Not a relevant route of exposure.

Justification for classification or non-classification

HAB is not irritating to the skin or eyes of laboratory animals in a GLP study; inhalation is not a relevant route of exposure.