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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: Study is done similar to OECD guideline 406.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used, under the same conditions as reported earlier (Wahlberg Boman, 1978)
Principles of method if other than guideline:
Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used. At intradermal induction 0.25 % of the drug in distilled water was used. At epicutaneous induction 20 % of the drug in petrolatum was used with previous SLS treatment. Challenge is by topical application. Provided there is no irritation. Challenge testing was performed on day 21 with 1, 5, and 10 % of the drugs in petrolatum. The chambers were left on the animals for 24 h. The challenge site is evaluated 24 hours and 48 hours after removal of the patch. The statistical method was chi-squared analysis.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Reference to existing guideline study (guinea pig maximization test). Additional animal testing is not considered necessary.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
other: water and petrolatum
Concentration / amount:
intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
Route:
epicutaneous, occlusive
Vehicle:
other: water and petrolatum
Concentration / amount:
intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
No. of animals per dose:
20
Details on study design:
MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 20- Concentrations: 0.25 % intradermal induction, 25 % epicutaneous inductionB. CHALLENGE EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 20- Day(s) of challenge: on day 21- Concentrations: 1 %, 5 % and 10 % of the drugs in petrolatum- Exposure period: 24h - other: readings were taken 24 and 48h after removal of the test chambers
Challenge controls:
20 control animals which get 1 %, 5 % and 10 % of the drugs in petrolatum
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 %
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: no data.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Quinine hydrochloride is a potent contact allergen.
Executive summary:

The contact sensitivity to quinine hydrochloride was experimentally determined in guinea-pigs. Quinine hydrochloride was found to be a grade V allergen according to Magnusson et al., 1969. 85 % and 95 % of the animals reacted to 5 % or 10 % of quinine hydrochloride, respectively and 25 % of the animals reacted to 1 % of quinine hydrochloride after 48 h. 80 % of the animals reacted to 10 % quinine hydrochloride and 85 % of the animals reacted to 5 % quinine hydrochloride after 24 h. 15 % of the animals reacted to 1 % quinine hydrochloride after 24 h. The control animals showed no reaction after 24 h and 48 h. Quinine hydrochloride is obviously a potent contact allergen and has to be classified.

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

The contact sensitivity to quinine hydrochloride was experimentally induced in guinea pigs. 95 % and 85 % of the animals reacted to 10 % or 5 % of quinine hydrochloride, respectively and 25 % of the animals reacted to 1 % of quinine hydrochloride after 48 h. 80 % of the animals reacted to 10 % quinine hydrochloride and 85 % of the animals reacted to 5 % quinine hydrochloride after 24 h. Only 15 % of the animals reacted to 1 % quinine hydrochloride after 24 h. The control animals showed no reaction after 24 h and 48 h. Quinine hydrochloride is obviously a potent contact allergen. Furthermore, it was shown in human that quinine is a contact allergen. Five patients were tested with a standard patch test and became sensitized after exposure.


Migrated from Short description of key information:
Quinine hydrochloride is obviously a potent contact allergen.

Justification for selection of skin sensitisation endpoint:
Study is done similar to OECD Guideline 406 on the read across substance quinine hydrochloride.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the guinea pig maximisation test, 95% of the animals reacted to 10 % of quinine hydrochloride after 48 h. According to CLP 1272/2008 regulation (Bühler Assay), more than 60 % of the animals reacted by a topical induction of > 0,2 % to ≤ 20 %. Therefore, quinine has to be classified category 1A (H317).