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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
441-810-8
EC Name:
-
Cas Number:
116313-85-0
Molecular formula:
C7H5NO5
IUPAC Name:
3,4-dihydroxy-5-nitrobenzaldehyde

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal induction:
0.5 % (w/v) in arachis oil BP
0.5 % (w/v) in FCA plus dist. water 1:1

b) topical induction
5 % (s/v) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
a) 0.5 % (w/w) in arachis oil BP
b) 0.2 % (w/w) in arachis oil BP
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal induction:
0.5 % (w/v) in arachis oil BP
0.5 % (w/v) in FCA plus dist. water 1:1

b) topical induction
5 % (s/v) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
a) 0.5 % (w/w) in arachis oil BP
b) 0.2 % (w/w) in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 2.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 % and 0.2%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 % and 0.2%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: .5 %

Signs of irritation during induction:

Intradermal induction:

Yellowish/orange discolouring was found at the induction spots of the test animals, which did not hinder the assessement of the erythema. Erythema grade 1-2 were found at the induction spots of all test animals. The grade 1 erythema were found in the control animals.

Topical induction:

Yellowish/orange dicolouring which prevented a exact assessment of erythema was found at the induction spots of all test animals 1 h and 24 h after plaster removing. Oedema grade 1-2 were also found at this times. Further adverse effects were small thin single incrustations, lost of skin elasticity and bleeding out off the intradermal induction spots.

A bleeding out off the indution spots was also found in 3 control animals 1 h after plaster removing.

Evidence of sensitisation of each challenge concentration:

10/10

Other observations:

The bodyweight development of animals in the testgroup from day 0 and ay 24 was similiar to the animals of the control group.

Yellowish/orange discolouring was found in the challenge areas of all test and control animals, but did not prevent the assessment of erythema and oedema.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information