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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
08 Mar - 08 Apr 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions. No positive controls were used to show the sensitivity and reliability of the assay.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive controls were used to show the sensitivity and reliability of the assay
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: yellow viscous liquid
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Germany (preliminary study)
- Weight at study initiation: main study: 308.6 (controls) and 310.0 g (test groups); preliminary study: 334.7 g (group A), 312.7 g (group B) and 322.7 g (group C)
- Housing: animals were housed in groups of 5 (preliminary study) or groups of 2-3 (main study) in Makrolon Type IV cages.
- Diet: Altromin-Haltungsdiät 3032 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
Concentration / amount:
Induction, intradermal: 0.1%
Induction, epicutaneous: 10%
Challenge: 1.25 and 2.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
Concentration / amount:
Induction, intradermal: 0.1%
Induction, epicutaneous: 10%
Challenge: 1.25 and 2.5%
No. of animals per dose:
20 (controls), 20 (test groups), 15 (preliminary study)
Details on study design:
RANGE FINDING TESTS:
A. Group A (5 animals) - Intradermal induction
- Test concentrations: 0.1, 0.5, 1.0 and 2.0%
- Results: 0.1% of the test substance was chosen for the main study, since it caused significant skin irritation and no necrosis.

B. Group B (5 animals) - Epicutaneous induction
Test concentrations: 5 and 10%
-Results: 10% of the test substance provoked slight skin irritation and eschar formation and was chosen as concentration for the main assay.

C. Group C (5 animals) - Challenge
Challenge: 2.5 and 5%
- Results: 2.5% of the test substance was selected for the main study, since 5% caused slight irritations in 4/5 animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA in 0.9% NaCl solution
Injection 2: test substance in 20% 1,2-propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: test substance in 1,2-propylene glycol

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA in 0.9% NaCl solution
Injection 2: 20% 1,2-propylene glycol
Injection 3: 20% 1,2-propylene glycol in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: 1,2-propylene glycol

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: twice (Day 1 and Day 8)
- Duration: Days 0-8
- Concentrations: intradermal 0.1%, epicutaneous 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance in 1,2-propylene glycol
- Control group: test substance in 1,2-propylene glycol
- Site: right flank (test substance)
- Concentrations: 1.25 and 2.5%
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 1.25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5%
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 2.5%. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1%; challenge: 1.25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.1%; challenge: 1.25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1%; challenge: 2.5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.1%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 1.25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1%; challenge: 1.25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.1%; challenge: 1.25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1%; challenge: 2.5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.1%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified