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Diss Factsheets

Administrative data

Description of key information

A GPMT (Guinea Pig Maximisation Test) is available. Twenty male albino guinea pigs were used to test the sensitizing potential of 1,4-dihydroxyanthraquinone.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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.
Species:
guinea pig
Strain:
not specified
Sex:
male
Route:
intradermal
Vehicle:
peanut oil
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
Route:
intradermal
Vehicle:
peanut oil
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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Only two of the 20 guinea pigs tested reacted when given the challenge injection. The mean score for each of the two guinea pigs indicates a severe response.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

In a guinea pig maximization test on 20 animals only 2 animals showed a positive reaction.

Justification for classification or non-classification

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.