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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Dichlorotoluene isomers was investigated in male guinea pigs according to the maximization test tested by Magnusson and Kligman for skin sensitizing properties.
The examination was carried out with the following test item concentrations:
Intradermal induction: 5%
Topical induction: 100%
Provocation: 50% and 25%
The test item was formulated in polyethylene glycol 400
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The GPMT test was conducted in 1992 - at this time point no valid guideline for a LLNA was available

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichloromethylbenzene
EC Number:
249-854-8
EC Name:
Dichloromethylbenzene
Cas Number:
29797-40-8
Molecular formula:
C7H6Cl2
IUPAC Name:
(dichloromethyl)benzene
Test material form:
other: liquid
Details on test material:
content: 99.1%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: BOR:DHPW
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25%
Challengeopen allclose all
Route:
other: epicutaneous, Fermoflex-Plaster (not defined if occlusive or not)
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25%
No. of animals per dose:
20 (test substance group); 10(control group).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
other: see 'Overall remarks, attachments'.
Remarks:
The sensitivity and reliability of studies according Magnusson and Kligman conducted in the testing facility performing the study with dichloromethylbenzene (Institute of Toxicology at the BAYER AG) were evaluated regularly as required by the test guideline. For the respective time period a separate report (Dreist M, BAYER Report n° 21251) is available. This report is available in German language: Dreist, M.: Ueberpruefung der im Fachbereich Toxikologie der BAYER AG angewandten Methodik des Maximierungstests nach Magnusson und Kligman am Meerschweinchenstamm DHPW unter Verwendung von alpha-Hexylzimtaldehyd BAYER-report Nr. 21251 from 1992-04-03.

Any other information on results incl. tables

Numbers of animals exhibiting skin redness (48 and 72 hours after initiation of challange):

            test substance group (20 animals)           First control group (10 animals)
      Test substance patch     Control patch     Test substance patch     Control patch
 Hours  48  72  48  72  48  72  48 72 
 Challenge                       
 50%  15  0  0  0  8  0  0 0
 25%  0  0  0  0  0  0  0  0

After the first challenge with the 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.

The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.

Under the conditions of the assay, no evidence of a skin sensitization potential was found for dichlorotoluene isomers.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was tested in male guinea pigs. The testing was performed with following test substance-concentrations:

Intradermal induction: 5%

Topic induction: 100%

Challenge: 50% and 25%

Polyethylene glycol 400 served as vehicle.

After the first challenge with a 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.

The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.

The substance is therefore not-sensitising to the skin.