Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
No data, presumably 7 days with detailed observations at 24, 48 and 72 hours
Number of animals:
3
Details on study design:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration; 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
No data. No effects noted.
Other effects:
COLOUR: No staining has been observed.
MORTALITY: No mortality during the test.
CLINICAL signs: No clinical signs has been observed during the test.
BODY weight: No change.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant
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. 

 

None irritant. The substance is not classified.