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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed similar to OECD guideline 406 (GPMT) at a time GLP was not enacted. Minor deviations from OECD guideline 406 occured.

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
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
concentration used for induction was not irritating
GLP compliance:
no
Remarks:
study was conducted prior to the enactment of GLP principles
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorocresol
EC Number:
200-431-6
EC Name:
Chlorocresol
Cas Number:
59-50-7
Molecular formula:
C7H7ClO
IUPAC Name:
4-chloro-3-methylphenol
Details on test material:
- Name of test material (as cited in study report): Preventol CMK
- Analytical purity: 100%
- Lot/batch No.: 54 603 00

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: Lippische Versuchstierzucht, Extertal, Germany
- Sex: ♂ (1st experiment), ♀ (2nd experiment)
- Weight at study initiation: 400 g (1st experiment); 300 g (2nd experiment)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Lutrol 300/ethanol (3:1)
Concentration / amount:
Intradermal induction (Day 0): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle and in Freund's adjuvant, respectively
Topical induction (Day 7): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle
Topical challenge (Day 21):
1st experiment: 25% (right flank), 12.5% CMK (left flank) in vehicle
2nd experiment: 50% (right flank), 25% CMK (left flank) in vehicle
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
other: Lutrol 300/ethanol (3:1)
Concentration / amount:
Intradermal induction (Day 0): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle and in Freund's adjuvant, respectively
Topical induction (Day 7): 25% (1st experiment) and 1% CMK (2nd experiment) in vehicle
Topical challenge (Day 21):
1st experiment: 25% (right flank), 12.5% CMK (left flank) in vehicle
2nd experiment: 50% (right flank), 25% CMK (left flank) in vehicle
No. of animals per dose:
15
Details on study design:
The skin irritating potential of the test substance was assessed in a pre-test with concentrations of 12.5%, 25%, 50% and 100% applied for 24 h under occlusive conditions.
The study followed the Magnusson-Kligman method which is basically compliant with OECD Guideline 406 (GPMT). However, this guideline was not available when the study was conducted.
The study comprised of two experiments each conducted on 15 Pirbright White guinea pigs. In the 1st experiment, male animals received intradermal (in vehicle and in Freund´s adjuvant) and topical induction treatments (in vehicle) with 25% test substance. In the 2nd experiment, females were induced with a 1% test substance via the same procedure. Both experiments included respective vehicle control groups (Lutrol 300/ethanol (3:1) with 15 animals each. The topical induction exposure lasted 48 h. The challenge treatment two weeks after the last induction application was performed with 25% (right flank) or 12.5% (left flank) test item in vehicle in the 1st experiment and with 50% (right flank) or 25% (left flank) test item in vehicle in the 2nd experiment. Each challenge exposure lasted 6 h. Animals of the control groups were challenged in the same way. The Magnusson-Kligman scoring system was used to rate the skin reactions. Scoring of the treated skin was performed 24 and 48 h after challenge.
Challenge controls:
Yes
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: challenge control
Dose level:
0% (12.5+25% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0% (12.5+25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% (12.5% challenge)
No. with + reactions:
1
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (12.5% challenge). No with. + reactions: 1.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% (25% challenge)
No. with + reactions:
7
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (25% challenge). No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge control
Dose level:
0% (12.5% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (12.5% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge control
Dose level:
0% (25% challenge)
No. with + reactions:
1
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (25% challenge). No with. + reactions: 1.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% (12.5% challenge)
No. with + reactions:
3
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (12.5% challenge). No with. + reactions: 3.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% (25% challenge)
No. with + reactions:
13
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (25% challenge). No with. + reactions: 13.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
1st reading
Hours after challenge:
24
Group:
other: challenge control
Dose level:
0% (25 + 50% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0% (25 + 50% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% (25% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% (50% challenge)
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (50% challenge). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge control
Dose level:
0% (25 + 50% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0% (25 + 50% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% (25% challenge)
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (25% challenge). No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: No findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% (50% challenge)
No. with + reactions:
2
Total no. in group:
15
Clinical observations:
No findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (50% challenge). No with. + reactions: 2.0. Total no. in groups: 15.0. Clinical observations: No findings.

Any other information on results incl. tables

The highest non-irritating concentration after topical dermal application for 24 h was determined as 50%. An short overview of the results is given in the table below.

Table 1: Animals with skin reactions after the challenge phase:

 

 Control

Experiment 1

Control

Experiment 2

Induction concentration

0%

25%

0%

1%

Challenge concentration

12.5%

25%

12.5%

25%

25%

50%

25%

50%

Time after challenge

 

24 h

0/15

0/15

1/15

7/15

0/15

0/15

0/15

0/15

48h

0/15

1/15

3/15

13/15

0/15

0/15

4/15

2/15

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Skin sens 1B, H317
DSD: Xi, R43