Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 10 December 1991 and 4 January 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
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:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
EEC Directive 84/449/EEC, Annex V, Method B6
Deviations:
yes
Remarks:
0.2 mL of sodium lauryl sulphate instead of 0.5 mL recommended in the guideline
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test carried out in 1992 before the advice to go for LLNA was issued

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): P-#620

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6 to 7 weeks of age
- Weight at study initiation: 302 to 367 g
- Housing: in groups of 10 in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): vitamin C-enriched guinea-pig diet F.D.1 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Results and discussion

Positive control results:
The sensitivity of the guinea-pig is checked periodically with formalin

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
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.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
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:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Signs of irritation during induction:
Intradermal injection: Necrosis was recorded at sites receiving Freund's complete Adjuvant in test and control animals.
Irritation was seen in test animals at sites receiving the substance, 20% v/v in Alembicol D.
Topical application: Very slight to moderate erythema in test animals with the substance as supplied.

Evidence of sensitisation of each challenge concentration: None.

Other observations:
No signs of ill health or toxicity were recorded in any animals during the observation period. Bodyweight gain appears normal in all animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the test conditions, P-#620 is not classified according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EC.
Executive summary:

In a dermal sensitization study performed according to the EU test method B.6 and in compliance with GLP, P-#620 (89.01% a.i.) was tested in female Dunkin/Hartley guinea-pigs using the Guinea-Pig Maximisation Test method (20 treated animals + 10 controls).

 

The preliminary study determined the lowest irritant test substance concentration used at induction phases and the highest non-irritant test substance concentration used at challenge.

P-#620 diluted in Alembicol D at 20% (v/v) was administered by intradermal injection for the induction. As the substance is not a skin irritant, 6 days after the injections the site was pre-treated with 0.2 mL of 10% w/w sodium lauryl sulphate in petrolatum. Then topical induction was performed with P-#620 as supplied on day 7.

For the challenge, P-#620 was tested at 100% and 50% (v/v in Alembicol D.).

 

The sensitivity of the guinea-pig is checked periodically at HRC with formalin, a known sensitizer.

 

No signs of ill health or toxicity were recorded in any animals during the observation period.

 

P-#620 did not produce evidence of skin sensitization (delayed contact hypersensitivity).

 

Under the test conditions, P-#620 is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.