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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buhler
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Available data provided by ECHA - study from 1991.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor. DHPW (SPF)
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
olive oil
Concentration / amount:
2000 mg/kg b.w in 1.0 ml olive oil applied
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
olive oil
Concentration / amount:
2000 mg/kg b.w in 1.5 ml olive oil applied
No. of animals per dose:
20 in test group,
20 in negative control.
Details on study design:
RANGE FINDING TESTS: Maximum concentration not giving rise to irritating effects in the preliminary test: 2000 mg/lg

MAIN STUDY
A. INDUCTION EXPOSURE
Test group: 2000 mg/kg bw in 1.0 ml olive oil (Application: 1.0 ml olive oil)
Control group: Yes

B. CHALLENGE EXPOSURE
- No. of exposures :1
Test group: 2000 mg/kg bw in 1.5 ml olive oil (Application: 1.5 ml olive oil)
Control group: Yes

During inuduction exposure animals were observed for signs of irritation.

After challanged exposure animals were observed at 24 and 48 hrs for evidence of sensitization.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

Signs of irritation during induction: None

Number of animals showing evidence of sensitization at challenge: None

Group

Challenge Concentration

Number of animals showing skin reactions after challenge

24 h

48 h

Test Group

2000 mg/kg

0/20

0/20

Control Group

 

0/20

0/20

Other Observations: No change in body weight was caused by the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not show any evidence of sensitisation in guinea pigs following induction and challenge at 2000 mg/kg bw.
0 of 20 animals (test and control groups) showed positive reactions for skin sensitization after challenge exposure.