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EC number: 226-394-6 | CAS number: 5392-40-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- First application (injection): 29 Mar 1978; last application (2rd rechallenge: 08 May 1978)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (modified grading scale; 2 rechallenges with non-irritating concentration)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA study protocol was not available when study was conducted.
Test material
- Reference substance name:
- Citral
- EC Number:
- 226-394-6
- EC Name:
- Citral
- Cas Number:
- 5392-40-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dienal
- Reference substance name:
- (Z)-3,7-dimethylocta-2,6-dienal
- EC Number:
- 203-379-2
- EC Name:
- (Z)-3,7-dimethylocta-2,6-dienal
- Cas Number:
- 106-26-3
- Molecular formula:
- C10H16O
- IUPAC Name:
- (2Z)-3,7-dimethylocta-2,6-dienal
- Details on test material:
- - Name of test material (as cited in study report): Citral synthetic; 2,6-Dimethyl-2,6-octadien-8-al; Substance No. 77/711
no further data
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Firma Hagemann, Lippische Versuchstierzucht, 4923 Extertal, Germany
- Weight at study initiation (injection): 507.7 g
- Diet: ad libitum; Sniff K, Standard-Diet for rabbits and guinea pigs, Intermast GmbH, Soest
- Water: ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and percutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1st application = intradermal induction:
- Freund´s adjuvant/aqua dest (1:1) without test substance
- 25 % test substance in paraffin oil DAB7
- 25 % test substance in paraffin oil DAB7 and Freund´s adjuvant/aqua dest. (1:1)
2nd application = Percutaneous induction:
- with 25 % test substance in paraffin oil DAB7
1st challenge: 10 % test substance in paraffin oil DAB7
1st rechallenge: 5 % test substance in paraffin oil DAB7
2nd rechallenge: 5 % test substance in paraffin oil DAB7
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1st application = intradermal induction:
- Freund´s adjuvant/aqua dest (1:1) without test substance
- 25 % test substance in paraffin oil DAB7
- 25 % test substance in paraffin oil DAB7 and Freund´s adjuvant/aqua dest. (1:1)
2nd application = Percutaneous induction:
- with 25 % test substance in paraffin oil DAB7
1st challenge: 10 % test substance in paraffin oil DAB7
1st rechallenge: 5 % test substance in paraffin oil DAB7
2nd rechallenge: 5 % test substance in paraffin oil DAB7
- No. of animals per dose:
- 10 per test group (10 for 1st challenge, 5 for rechallenges), 5 per control group (animals with challenge treatment only)
- Details on study design:
- RANGE FINDING TESTS:
A range finding test was conducted to determine the concentration of the test substance which caused no and mild-to-moderate skin irritation, respectively. No further information given.
MAIN STUDY
A. INDUCTION EXPOSURE
- 1x6 intradermal injections and one week later, treatment with SLS, followed by one percutaneous induction according to OECD 406
- Readings: 24 hours after the intradermal application and 48 hours after the percutaneous induction
- Control group: not treated during induction phase
- Site: shoulder, respective on the same area
B. CHALLENGE EXPOSURE
- No. of exposures: 3 challenges
- Day(s) of challenge: 1st challenge: 19 days after percutaneous induction, 1st rechallenge: 28 days after percutaneous induction, 2nd rechallenge: 33 days after percutaneous induction
- Site: 1st challenge: right flank, 1st rechallenge: left flank, 2nd rechallenge: right flank
- Concentrations: 1st challenge: 10 % test substance in paraffin oil DAB7, 1st and 2nd rechallenge: 5 % test substance in paraffin oil DAB7
- Evaluation (hr after challenge): 1st challenge: treated and control animals 48 and 72 hours; 1st rechallenge: treated animals only 24 h, control animals 24 and 72 h; 2nd rechallenge: treated and control animals 24, 48 and 72 h. - Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge, 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- well-defined to moderate erythema, well-defined edema exceeding beyond the area of exposure
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st challenge, 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % . No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: well-defined to moderate erythema, well-defined edema exceeding beyond the area of exposure .
- Reading:
- other: 1st challenge, 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- well-defined to moderate erythema and well-defined edema exceeding beyond the area of exposure
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st challenge, 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10 % . No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: well-defined to moderate erythema and well-defined edema exceeding beyond the area of exposure.
- Reading:
- other: 1st challenge, both readings
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- primary irritation: slight to well-defined erythema, no edema
- Remarks on result:
- other: Reading: other: 1st challenge, both readings. Group: negative control. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: primary irritation: slight to well-defined erythema, no edema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- well-defined to moderate erythema and well-defined edema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % . No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: well-defined to moderate erythema and well-defined edema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % . No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 2nd rechallenge, 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- moderate erythema and well-defined edema, both beyond the area of exposure
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 2nd rechallenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: moderate erythema and well-defined edema, both beyond the area of exposure.
- Reading:
- other: 2nd rechallenge, 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- well-defined erythema and edema
- Remarks on result:
- other: Reading: other: 2nd rechallenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % . No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: well-defined erythema and edema.
- Reading:
- other: 2nd rechallenge, 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- slight to well-defined erythema and desquamation
- Remarks on result:
- other: Reading: other: 2nd rechallenge, 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5 % . No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: slight to well-defined erythema and desquamation.
- Reading:
- other: 2nd rechallenge, all readings
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 2nd rechallenge, all readings. Group: negative control. Dose level: 5 % . No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Challenge |
Group |
Substance application |
Number of animals with skin reaction |
Erythema score and incidence |
Edema score and incidence |
Findings |
1st ch |
test group |
10 % test substance in paraffin oil |
10/10 |
2 in 4/10 3 in 6/10 |
2 in 10/10 |
well-defined to moderate erythema, well-defined edema exceeding beyond the area of exposure |
negative control |
10 % test substance in paraffin oil without induction |
5/5 |
1 in 3/5 |
0 in 5/5 |
slight to well-defined erythema, no edema |
|
1st ch |
test group |
10 % test substance in paraffin oil |
10/10 |
2in 9/10 |
2 in 10/10 |
well-defined to moderate erythema and well-defined edema: exceeding beyond the area of exposure |
negative control |
10 % test substance in paraffin oil without induction |
5/5 |
1 in 5/5 |
0 in 5/5 |
slight erythema, no edema |
|
2nd ch |
test group |
5 % test substance in paraffin oil |
5/5 |
2 in 3/5 3 in 2/5 |
2 in 5/5 |
well-defined to moderate erythema and well-defined edema |
2nd ch |
negative control |
5 % test substance in paraffin oil without induction |
0/5 |
0 in 5/5 |
0 in 5/5 |
|
3rd ch |
test group |
5 % test substance in paraffin oil |
5/5 |
3 in 5/5 |
2 in 5/5 |
moderate erythema and well-defined edema: both exceeding beyond the area of exposure |
3rd ch |
test group |
5 % test substance in paraffin oil |
5/5 |
2 in 5/5 |
2 in 5/5 |
well-defined erythema and edema |
3rd ch |
test group |
5 % test substance in paraffin oil |
5/5 |
1 in 4/5 2 in 1/5 |
0 in 5/5 |
Slight to well-defined erythema and desquamation |
3rd ch |
negative control |
5 % test substance in paraffin oil without induction |
0/5 |
0 in 5/5 |
0 in 5/5 |
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