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Diss Factsheets

Administrative data

Description of key information

Durferrit REG 1 was applied to the skin of guinea pigs to determine its sensitizing properties by the Buehler method. None of the animals showed deviations from normal skin appearance at the exposed sites. REG 1 is not sensitizing to the skin of the guinea pig.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-07-05 - 1994-10-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline (OECD 406). All study parameters are based on the specific guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The Bühler-Testreport from 1994 ist considered as reliable source. No additional study with experimental animals was performed
Species:
guinea pig
Strain:
other: Hsd/Win: DH
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 g (50% suspension)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 g (50% suspension)
No. of animals per dose:
10
Details on study design:
Induction:

- Route of Application: Epidermally (occlusive patch)

- Area of exposure: 3 x 3 cm of the left flank

- Type of wrap: Filter paper with leaf aluminium (2x2 cm)

- Duration of the Induction Phase: 15 days

- Application Days: Days 1, 8, and 15

- Duration of Application: 6 hours

- Total Number of Applications: 3

Challenge:

- Route of Application: Epidermally (occlusive patch)

- Patch Material: Filter paper with leaf aluminium (2x2 cm)

- Duration of Application: 6 hours

- Application Day: Day 29

- Repetition of the Challenge: As the result of the first challenge was unequivocal a second challenge was not performed. The animals Nos. 7 - 9 and 10-12 were left untreated.


Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None of the animals of the treated as well as the control groups showed changes at the exposed skin. No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None of the animals of the treated as well as the control groups showed changes at the exposed skin. No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected. .
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None of the animals of the treated as well as the control groups showed changes at the exposed skin. No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None of the animals of the treated as well as the control groups showed changes at the exposed skin. No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected. .
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: results not reported
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Durferrit REG 1 was applied to the skin of guinea pigs to determine its sensitizing properties by the Buehler method. None of the animals showed deviations from normal skin appearance at the exposed sites. REG 1 is not sensitizing to the skin of the guinea pig.
Executive summary:

Durferrit REG 1 was applied to the skin of guinea pigs to determine its sensitizing properties by the Buehler method. None of the animals showed deviations from normal skin appearance at the exposed sites. REG 1 is not sensitizing to the skin of the guinea pig.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Justification for selection of skin sensitisation endpoint:

only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The respective citeria are not met.

As a result the substance has not to be classified according to Regulation (EC) No 1272/2008 (CLP/GHS).