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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: Letter of Access (See Section 13)
Adequacy of study:
key study

Data source

Reference
Reference Type:
other: Letter of Access (See Section 13)
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
not specified
Remarks:
Letter of Access Only
Type of study:
Freund's complete adjuvant test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
417-560-0
EC Name:
-
Cas Number:
67881-98-5
Molecular formula:
C11H22NO6P
IUPAC Name:
trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
At induction, an intradermal injection of 10 % (w/w) in water was used and a topical application of 95.2 % (w/w) in distilled water.
The single challenge dose was applied topically at two concentrations: 60 % and 30 % (w/w) in distilled water.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
At induction, an intradermal injection of 10 % (w/w) in water was used and a topical application of 95.2 % (w/w) in distilled water.
The single challenge dose was applied topically at two concentrations: 60 % and 30 % (w/w) in distilled water.
No. of animals per dose:
10 animals per dose group and 5 animals in the negative control group.
Challenge controls:
5 animals were used as a control group for each of the two test concentrations.
Positive control substance(s):
no

Results and discussion

Positive control results:
N/A

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60 % (w/w)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % (w/w). No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60 % (w/w)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % (w/w). No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 % (w/w)
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % (w/w). No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 % (w/w)
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % (w/w). No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60 % (w/w)
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 1.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60 % (w/w)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 % (w/w)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 % (w/w)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Signs of irritation during induction:

Intradermal injection: Necrosis was recorded at sites receiving Freud's Complete Adjuvant in test and control animals. Slight irritation was seen in test animals at sites receiving the HEMA-PC, 10 % (w/w) in water for irrigation. No irritation was observed in control animals receiving water for irrigation.

Topical Application: Slight erythema was observed in test animals following application of HEMA-PC, 95.2 % (w/w) in distilled water. Very slight erythema was seen in the control group animals.

Table 1. Results of Skin Sensitisation Challenge

Number of animals showing sjin reactions

1st Challenge

Challenge Concetration of Test Substance (% w/w)

24 hour

48 hour

Test Group

60

30

10

7

10

5

Negative Control Group

60

30

1

0

0

0

Other Observations:

No signs of inn-health or toxicity were recorded.

Comments:

The dermal reactions seen in all ten test animals in the 60 % (w/w) concentration were more marked than in the controls and were considered to indicate a positive sensitisation response.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The results of this test indicate that HEMA-PC is sensitising to the skin.
Executive summary:

A skin sensitising study was conducted on HEMA-PC using OECD Guideline 406 (Skin Sensitisation) and EU Method B.6 (Skin Sensitisation). The results of this test indicate that HEMA-PC is sensitising to the skin.