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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using 12 years rule and this data is not owned by the registrant. The reliability is estimated to be at least level 2 at a minimum. Therefore the reliability statement below can be used:
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.6 (Guinea pig maximization test (GMPT))
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation 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
Details on test material:
No data.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No data.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection: 10% w/w in water for rinsing
topic application: 95.2% w/w in aqua dest.
Concentration of test material and vehicle used for each challenge:
Topical challenge: 60% and 30% w/w in destilled water.
Challengeopen allclose all
Route:
other: no data
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal injection: 10% w/w in water for rinsing
topic application: 95.2% w/w in aqua dest.
Concentration of test material and vehicle used for each challenge:
Topical challenge: 60% and 30% w/w in destilled water.
No. of animals per dose:
10 for test group,
Details on study design:
No data.
Challenge controls:
5 for negative control group.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
60%
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%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
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%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
60%
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%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
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%. No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60%
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%. No with. + reactions: 1.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
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%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60%
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%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
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%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 60%

 

Signs of irritation during induction:

Intradermal injection: Necroses at spots which were treated with Freunds adjuvans in test and control animals.

 

Slight irritation was observed at test animals receiving 10% test substance in water for rinsing.

 

Topic application: slight erythemes in test animals. Very slight erythemes in controls.

Evidence of sensitisation of each challenge concentration: 10

 

Other observations: There were no signs of illness or toxicity shown.

 

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Significant sensitising reactions were seen in all 10 animals comparing to the control group. The substance was considered to be a skin sensitiser under the conditions of the test. The test material is classified as R43 May cause sensitisation by skin contact under Council Directive 67/548/EEC and Category 1 H317: May cause an allergic skin reaction under under Regulation (EC) No 1272/2008.
Executive summary:

Significant sensitising reactions were seen in all 10 animals comparing to the control group. The substance was considered to be a skin sensitiser under the conditions of the test.The test material is classified as R43 May cause sensitisation by skin contact under Council Directive 67/548/EEC and Category 1 H317: May cause an allergic skin reaction under under Regulation (EC) No 1272/2008.

Reliability of the data is not assigned but expected to be 2 at minimum.