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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
-
EC Number:
432-130-2
EC Name:
-
Cas Number:
119345-01-6
Molecular formula:
Not applicable ( a generic molecular formula cannot be provided for this UVCB substance)
IUPAC Name:
Reaction products of phosphorous trichloride, with 1,1′-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol
Details on test material:
No data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction lntradermal:
1) 0.1 ml solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% substance of essal in una solution CFA: physiological saline (50: 50)
Induction epidermale: 75% in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
Induction lntradermal:
1) 0.1 ml solution CFA: physiological saline (50: 50)
2) 1% test substance in TWEEN 80
3) 1% substance of essal in una solution CFA: physiological saline (50: 50)
Induction epidermale: 75% in TWEEN 80
Concentration of test substance material and vehicle used for each challenge: 75% test substance in TWEEN 80
No. of animals per dose:
Number of animals in test group: 20
Number of animals In negative control group: 10
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

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:
75%
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: 75%. 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:
75%
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: 75%. 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:
75%
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: 75%. 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:
75%
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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75%

Signs of irritation during induction: test group: 0/20 animals displayed oedema or erythema after the induction. 

Negative Control group: 0/5 animals displayed oedema or erythema after the induction. 

Evidence of sensitisation of each challenge concentration: 75%: 0 / 20 animals

 

Other observations: mortality: no mortality during the test.

 

Clinical signs: No clinical signs have been observed during the test.  

 

Body weight: No changes were noted.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified
Executive summary:

Information from migrated NONS file, as per inquiry number 06-0000020725-70-0000, permission to refer granted by ECHA.

 

Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA. 

 

Not sensitising. The substance is not classified.