1,4-dihydroxyanthraquinone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

GPMT on male albino guinea pigs

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The study was published 1979. At this time an OECD guideline for a LLNA was not available.

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dihydroxyanthraquinone

EC Number:

201-368-7

EC Name:

1,4-dihydroxyanthraquinone

Cas Number:

81-64-1

Molecular formula:

C14H8O4

IUPAC Name:

1,4-dihydroxy-9,10-dihydroanthracene-9,10-dione

Test material form:

other: solid

Details on test material:

1,4-dihydroxyanthraquinone (solid) - no further data

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

peanut oil

Induction 2

Concentration / amount:

induction: 0.05 ml and 0.1 ml of a 0.1% dilution in peanut oil
challenge: 0.05 ml of the 0.1% dilution

Challenge

Challenge 1

Route:

intradermal

Vehicle:

peanut oil

Challenge 2

Concentration / amount:

induction: 0.05 ml and 0.1 ml of a 0.1% dilution in peanut oil
challenge: 0.05 ml of the 0.1% dilution

No. of animals per dose:

20 male albino guinea pigs

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: 1st and 2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.05 and 0.1 ml

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

other: Reading: other: 1st and 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05 and 0.1 ml. No with. + reactions: 2.0. Total no. in groups: 20.0.

Any other information on results incl. tables

The categorization of 1,4-dihydroxyanthraquinone as a compound with "slight" sensitization potential resulted when only two of

the 20 guinea pigs tested reacted when given the challenge injection. The mean score for each of the two guinea pigs that reacted was over 800 which indicates a severe response. The mean for the entire group response diluted out the severity of this reaction and while only a small portion of any population might react to this material, the reaction for these individuals can be very intense.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guinea pig maximization test on 20 animals only 2 animals showed a positive reaction. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.

Executive summary:

In a guinea pig maximization test on 20 animals only 2 animals showed a positive reaction. According to amendment of regulation n° 286/2011 of regulation 1272/2008 EU a classification is not justified, as the number of animals with a positive reaction is too low for a classification.