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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:
1979-05-28 - 1979-07-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Light period of 10 hours light. incomplete series of induction in test and control groups.
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. Guinea Pig optimization tests like the Maurer optimization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: organic
- Physical state: solid, white powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 380 - 500 g
- Housing: individually in Macrolon cages, type 3
- Diet (e.g. ad libitum): ad libitum, standard guinea pig pellets (NAFAG, No. 830, Gossau SG)
- Water (e.g. ad libitum): ad libitum

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
Concentration / amount:
0.1%
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
Concentration / amount:
0.1%
Day(s)/duration:
on Day 35, duration 24h
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: 70 % propylene glycol in saline (induction and challenge) and Petrolatum (rechallenge)
Concentration / amount:
0.1%
Day(s)/duration:
On day 45; duration 24h
No. of animals per dose:
10 males and 10 females
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: -
- Test groups: test substance + vehicle (first week) and test substance + vehicle:FCA (1:1) (second and third week)
- Control group: vehicle
- Site: right flank and back
- Frequency of applications: every second day (except weekends)
- Duration: 0-21 d- Concentrations: 0.1 %

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 35 and 45
- Exposure period: -
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 0.1 %
- Evaluation (hr after challenge): 24
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
The exact Fisher test for comparison of the basic probability of two binominal distributions; L. Sachs, Statistische Auswertungsmethoden, Thieme Verlag, Stuttgart, 1971. A probability of ≤ 0.01 was considered to indicate a significant difference.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
3
Total no. in group:
19
Clinical observations:
one animal (male) died
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 %
No. with + reactions:
10
Total no. in group:
19
Clinical observations:
one animal (male) died
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.1 %
No. with + reactions:
0
Total no. in group:
18
Clinical observations:
one animal (female) died

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.