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Description of key information

A guinea pig maximisation study was carried out to determine the skin sensitisation potential of the substance BMS 217947-01. The substance (50% w/v) induced an allergic skin reaction to all 9 animals that survived the 21 -day observation period (one was killed for humane reasons). It is therefore considered to be an "extreme sensitiser" and is classified as Skin Sensitiser, Category 1B, according to the CLP Regulation.

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:
16th Nov 1998 - 25th Dec 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method
Qualifier:
according to guideline
Guideline:
other: Directive 96/54/EC, Method B6;OECD Guideline No.406
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted prior to amendments to Annex VII
Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
albino
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: 10% w/v in arachis oil BP

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: 10% w/v in arachis oil BP

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
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: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd 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: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
2nd reading
Hours after challenge:
48
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: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 5 %

Signs of irritation during induction:
Very slight to well-defined erythema with or without very
slight to slight oedema was noted at the topical induction
sites of all test group animals at the 1-hour observation.
Well-defined erythema with very slight oedema persisted at
the topical induction sites of two test group animals at the
24-hour observation. Bleeding from the intradermal injection
sites was noted in eight test group animals with subsequent
small superficial scattered scabs, hardened dark
brown/black-coloured scabs or hardened light brown-coloured
scabs. These adverse reactions precluded accurate assessment
of the erythema and oedema at the other topical induction
sites at the 24-hour observation.

No erythema or oedema was noted at the topical induction
sites of control group animals at the 1 and 24-hour
observations. Bleeding from the intradermal injection sites
was noted in three control group animals at the 1-hour
observation.

Evidence of sensitisation of each challenge concentration:
The test material produced a 100% (9/9) sensitisation rate.

Other observations:
One test animal was killed for humane reasons on Day 21.

After the topical challenge with 50% (w/v)
substance,positive skin responses (erythema grade 1 or 2)
with or without very slight to slight oedema (grade 1 or 2)
was noted at the challenge sites of all test groups animals
at the 24 and 48 hour observations.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test substance requires labelling with the risk phrase R43 "May cause sensitisation by skin contact". This corresponds to Category 1 Skin Sensitisation according to CLP Regulation. This substance gave a response in 100% of animals at both doses used. It therefore appears to be an extreme sensitizer.
Executive summary:

A guinea pig maximisation study was carried out to determine the skin sensitisation potential of the substance BMS 217947-01. The substance (50% w/v) induced an allergic skin reaction to all 9 animals that survived the 21 -day observation period (one was killed for humane reasons). It is therefore considered to be an "extreme sensitiser" and is classified as Skin Sensitiser, Category 1B, according to the CLP Regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

The substance (50% w/v) induced an allergic skin reaction to all 9 animals that survived the 21 -day observation period (one was killed for humane reasons). It is therefore considered to be an "extreme sensitiser" and is classified as Skin Sensitiser, Category 1B, according to the CLP Regulation.