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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
other: Guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
other: Freud´s Adjuvant, sterile saline, vaseline, paraffin
Concentration / amount:

see: Any other Information on materials and methods
Route:
epicutaneous, occlusive
Vehicle:
other: Freud´s Adjuvant, sterile saline, vaseline, paraffin
Concentration / amount:

see: Any other Information on materials and methods
No. of animals per dose:
5
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
erythema scores 1-3; edema scores 1-2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema scores 1-3; edema scores 1-2.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
control
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: control. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
erythema scores: 1-3; edema scores: 0-2;
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema scores: 1-3; edema scores: 0-2; .

SO-Freetext: Hoechst AG  Frankfurt 80
Hoechst AG  Frankfurt/Main

RM-Freetext:
24 bis 48 h nach der Ausloesebehandlung konnten bei allen
Tieren kaum wahrnehmbare bis mittelschwere Erytheme und
sehr leichte Oedeme beobachtet werden, die Haut war
teilweise trocken und sproede.

Executive summary:

In a sensitisation test (Maximization test) in female Pirbright-White-guinea pigs the treatment was executed as follows:

The intradermal induction treatment took place with 5 % test substance in Paraffin viscous DAB; the dermal induction treatment and the dermal challenge treatment with 25 % test substance in Vaseline white DAB.

Slight to medium-severe erythema and very slight to slight edema could be observed after 24 to 48 hours after bandage removal.

Additionally the skin was dry and rough. The animals of the control group showed no signs of irritation.

The test substance was found to be sensitizing according to EG-directive 83/467/EWG.

Therefore the substance was classified as R 43.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a sensitisation test (Maximization test) in female Pirbright-White-guinea pigs the treatment was executed as follows:

The intradermal induction treatment took place with 5 % test substance in Paraffin viscous DAB; the dermal induction treatment and the dermal challenge treatment with 25 % test substance in Vaseline white DAB.

In 20/20 guinea pigs slight to medium-severe erythema and very slight to slight edema could be observed after 24 to 48 hours after bandage removal.

Additionally the skin was dry and rough. The animals of the control group showed no signs of irritation.

The test substance was found to be sensitizing according to EG-directive 83/467/EWG.

Therefore the substance was classified as R 43 (Hofmann/Jung, Hoechst AG, 1988).


Migrated from Short description of key information:
In a sensitisation test (Maximization test) in female Pirbright-White-guinea pigs the treatment was executed as follows:
The intradermal induction treatment took place with 5 % test substance in Paraffin viscous DAB; the dermal induction treatment and the dermal challenge treatment with 25 % test substance in Vaseline white DAB.
In 20/20 guinea pigs slight to medium-severe erythema and very slight to slight edema could be observed after 24 to 48 hours after bandage removal.
Additionally the skin was dry and rough. The animals of the control group showed no signs of irritation.
The test substance was found to be sensitizing according to EG-directive 83/467/EWG.
Therefore the substance was classified as R 43 (Hofmann/Jung, Hoechst AG, 1988).

Justification for selection of skin sensitisation endpoint:
the study is performed according to the respective guideline and GLP and evaluated with Klimisch Score 1

Justification for classification or non-classification

Based on the available data and according to Regulation (EC) No. 1272/2008, 2. ATP, the substance has to be evaluated as skin sensitizer and allocated to Category 1 B (H317) of the skin sisitizing substances.

According to EG-Directive 83/467/EWG the substance was classified as skin sensitizer and labelled with R 43 = may cause skin sensitization.