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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Apr-May, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted equivalent or similar to EU Method B.6. and OECD Guideline 406 in compliance with GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Barriered Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: Young adults
- Weight at study initiation: 347-426 g females; 328-412 g males
- Housing: Individually housed in suspended cages (37cm length x 32cm width x 20cm height)
- Diet (e.g. ad libitum): Labsure RGP guinea pig diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: Minimum of 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Sighting Study: intradermal injection (induction): 0.3, 1, 3 and 10 %.
Topical application (induction): 60 %
Topical application (challenge): 3, 10, 30 and 60 %
Main study: Induction: 30 and 60 %; Challenge: 30 & 60 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Sighting Study: intradermal injection (induction): 0.3, 1, 3 and 10 %.
Topical application (induction): 60 %
Topical application (challenge): 3, 10, 30 and 60 %
Main study: Induction: 30 and 60 %; Challenge: 30 & 60 %
No. of animals per dose:
Sighting study: 2 or 4 guinea pigs and four dose-levels were on each group of animal
Main study: 30 females (20 test and 10 control)
Details on study design:
RANGE FINDING TESTS: Sighting study
Intradermal injection (induction): Test substance in deionised water: 0.3, 1.0 and 10 %
Topical application (induction): Test substance in corn oil: 60 %: To determine the highest concentration which did not cause greater than a mild to moderate irritation response in animals that had been injected with Freund's Complete Adjuvant at least 14 d previously.
Topical application (challenge): Test substance in corn oil (3, 10, 30 and 60 %): To determine the highest concentration which did not produce irritation in animals that had been injected with Freund's Complete Adjuvant at least 14 d previously

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1-14 d
- Test groups: Yes
- Control group: Yes
- Site: Scapular region of each animal and a row of three injections (0.05-0.1 mL each) on each side of the mid-line
- Frequency of applications: 1 in 7 d.
- Duration: 14 d
- Concentrations: 30 & 60 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: Occlusive dressing consisted of four pieces of filter paper (1 cm x 1.5-2.0 cm) stitched to a piece of rubber sheeting (size 12cm x 5cm).
- Test groups: Yes, 30 & 60 % of test substance in corn oil( 0.05-0.1 mL)
- Control group: Yes
- Site: Scapular region of each animal and a row of three injections (0.05-0.1 mL each) on each side of the mid-line
- Concentrations: 60, 30, 10 and 3 %
- Evaluation (hr after challenge): 24 h

OTHER: As all the challenge sites were stained blue by the test sample, it was not possible to visually assess the inflammatory response and the 60% and 30% challenge sites were submitted for histopathological examination
Positive control substance(s):
yes
Remarks:
10% w/v preparation of a formaldehyde solution (40% w/v in water)

Study design: in vivo (LLNA)

Vehicle:
other: Not applicable
Concentration:
Not applicable

No. of animals per dose:
Not applicable

Details on study design:
Not applicable

Positive control substance(s):
other: Not applicable
Statistics:
Not applicable

Results and discussion

Positive control results:
Challenge with a 10 % w/v dilution of a 40 % w/v aqueous formaldehyde solution elicited an extreme skin sensitisation response in previously-induced guinea pigs

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10& 3 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10& 3 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10& 3 %
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10& 3 %. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60 &30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 &30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60 &30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 &30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: -.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 %
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
-
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: -.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

Other observations:

Since all challenge sites were stained blue by the test sample, the inflammatory response could not be assessed visually. 60% and 30% challenge sites were examined histopathologically.

The examination showed a mild inflammatory reaction of slight focal, multifocal or diffuse acanthosis and minimal to slight focal or multifocal inflammatory cell infiltration at both challenge sites in test and control animals. The results indicate a mild skin irritation rather than sensitisation response. Results:

Challenge of previously-induced guinea pigs with 60 and 30% w/v suspensions of the test sample in corn oil did not elicit a skin sensitisation response but did cause mild skin irritation.

It is considered very unlikely that histopathological examination of the 10 and 3% w/v challenge sites would have revealed evidence for a sensitisation response.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance is not a skin sensitizer in guinea pigs.
Executive summary:

A study was conducted to assess the sensitizing potential of the test substance in guinea pigs (Magnusson & Kligman method) equivalent or similar to EU Method B.6. and OECD guideline 406.

Following challenge of previously-induced guinea pigs with 60, 30, 10 and 3% w/v suspensions of the test sample (corrected for water content) in corn oil the challenge sites were stained blue by the test sample. Skin samples were therefore submitted for histopathological examination.

Histopathological examination of the 60 and 30% w/v challenge sites indicated that the test sample was not a sensitiser. The test sample was, however, a mild skin irritant. It is considered very unlikely that histopathological examination of the 10 and 3% w/v challenge sites would have revealed evidence for a sensitisation response.

One test animal was killed due to irritation, prior to challenge, and this animal has therefore been excluded from the results.

In a positive control study, challenge of previously-induced guinea pigs with a 10% w/v dilution of a 40% w/v aqueous formaldehyde solution elicited an extreme skin sensitisation response.

Under the conditions of the present study, the test substance is not a skin sensitizer in guinea pigs (Parr-Dobrzanski R J & Leah AM, 1991).