Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles (no positive control group, no naive challenge group, negative control group only treated with vehicle at challenge/re-challenge, TS purity not provided; no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Principles of method if other than guideline:
Maurer Guinea Pig Optimisation Test
GLP compliance:
no
Type of study:
Maurer optimisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: red powder
- Lot/batch No.: EN 97004
No additional details provided

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Pirbright White strain bred on the premises
- Weight at study initiation: 350-450 g
- Housing: individually in Macrolon cages, type 3
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG, No. 8 3 0 , Gossau SG, Switzerland, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 10/14

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: propylene glycol or Vaseline
Concentration / amount:
0.1% or 30%
Challengeopen allclose all
Route:
other: intradermal (challenge) and epicutaneous, occlusive (re-challenge)
Vehicle:
other: propylene glycol or Vaseline
Concentration / amount:
0.1% or 30%
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections
- Test groups: freshly prepared suspension of the test substance in polyethylene glycol (first week); during the second and third week, the test substance was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (polyethylene glycol : adjuvant = 1 : 1)
- Control group: polyethylene glycol alone
- Site: on the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and on the back, while on the following days a single intracutaneous injection was given into the back.
- Frequency of applications: every second day
- Duration: 3 weeks
- Concentrations: 1%

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after the last induction
- Test groups: freshly prepared suspension of the test substance in polyethylene glycol
- Control group: polyethylene glycol alone
- Site: skin of the left flank
- Concentrations: 1%
- Evaluation (hr after challenge): 24
The “reaction volume” was obtained by measuring the two largest perpendicular diameters (in mm) and the increase in the skin-fold thickness (in mm). The mean volume plus one standard deviation of the induction reactions observed in the individual animals in the first week was taken as representing the skin irritation threshold for each animal. Any challenge reaction greater than this threshold value was graded as an allergic reaction and the animals termed positive

C. RE-CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of re-challenge: 10 days after the intracutaneous challenge injection, a sub-irritant dose of the test substance was applied epicutaneously under occlusive condition
- Exposure period: 24 hours
- Test groups: test substance in Vaseline
- Control group: Vaseline alone
- Concentrations: 30%
- Evaluation (hr after re-challenge): 24 hours (according to the Draize scoring system
Challenge controls:
Naive challenge not used
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Intradermal challenge
Hours after challenge:
24
Group:
test group
Dose level:
0.1% in polyethylene glycol
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: other: Intradermal challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% in polyethylene glycol. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
other: Intradermal challenge
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle alone (polyethylene glycol)
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: other: Intradermal challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle alone (polyethylene glycol). No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
other: epicutaneous re-challenge
Hours after challenge:
24
Group:
test group
Dose level:
30% in Vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: epicutaneous re-challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30% in Vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: epicutaneous re-challenge
Hours after challenge:
24
Group:
negative control
Dose level:
Vehicle alone (Vaseline)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: epicutaneous re-challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: Vehicle alone (Vaseline). No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Table 1: Body weights and body weight gains

 

Body weights (± standard deviations) and body weight gains (g)

Vehicle control group

Test substance group

Body weights

Body weight gains

Body weights

Body weight gains

Males

Females

Males

Females

Males

Females

Males

Females

Pre test

455±21

423±35

 

448±43

430±29

 

End of the test

590±36

512±25

+135

+89

546±51

500±44

+98

+70

 

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information