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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion:

Durferrit REG 1 was tested for skin corrosive/irritating properties on the skin of rabbits. Neither erythema nor edema could be detected. REG 1 is non-irritant to the skin of rabbits.

Eye irritation:

Durferrit REG 1 was tested for eye irritating properties in the rabbit eye.Observed eye lesions included hyperemia, diffuse redness, slight discharge or discharge with moistening of lids and hair. The symptoms were fully reversible after 48 hours. It is concluded that REG 1 is non-irritant to the eyes of the rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-05-05 - 1994-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline (OECD 404). All study parameters are based on the specific guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: White russian (Albino)
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
2 males, 1 female
Details on study design:
One day before treatment the dorsal skin area between shoulder and sacrum was clipped free of hair. To ensure a tight contact with the skin 0.5 g of the test substance was grinded in a ball mill and moistened with 0.5 ml demineralized water and was given on the left site of the vertebral column. The site of application was covered with a patch (6.25 cm2).
The opposite area of the dorsal skin was treated in the same way but without test substance (control site). A bandage wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; supplied by P. Beiersdorf and Co.AG, D-20245 Hamburg) provided a complete occlusion. After the end of the exposition time remaining test material was gently washed off as far as possible.
The treated skin area was assessed qualitatively (erythema/eschar resp. edema) and quantitatively (values 0 - 4) using the Draize method (1, 2, 4, 5). In addition, attention was paid to the occurrence of further reactions on the skin (e.g. corrosive effects) and to clinical symptoms (systemic toxic effects).

Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
8
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Durferrit REG 1 was tested for skin corrosive/irritating properties on the skin of rabbits. Neither erythema nor edema could be detected. REG 1 is non-irritant to the skin of rabbits.
Executive summary:

Durferrit REG 1 was tested for skin corrosive/irritating properties on the skin of rabbits. Neither erythema nor edema could be detected. REG 1 is non-irritant to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-05-25 - 1994-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline (OECD 405). All study parameters are based on the specific guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: White russian (Albino)
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
44.7 - 49.3 mg (representing a volume of about 0.1 ml)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
After grinding in a ball mill 44.7 - 49.3 mg (representing a volume of about 0.1 ml) of the powdered test substance were applied into the conjunctival sac of the left or right eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. The treated eye was not rinsed. The treated eye was examined using a Cliptrix pencil light (supplied by Varta, D-30419 Hannover, No. 645). Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the DRAIZE scale (1, 2, 4, 5). In addition, attention was paid to the occurrence of further reactions on the eye (e.g. corrosive effects) and to clinical symptoms (systemic toxic effects).
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Durferrit REG 1 was tested for eye irritating properties in the rabbit eye.
Observed eye lesions included hyperemia, diffuse redness, slight discharge or discharge with moistening of lids and hair. The symptoms were fully reversible after 48 hours. It is concluded that REG 1 is non-irritant to the eyes of the rabbit.
Executive summary:

Durferrit REG 1 was tested for eye irritating properties in the rabbit eye. Observed eye lesions included hyperemia, diffuse redness, slight discharge or discharge with moistening of lids and hair. The symptoms were fully reversible after 48 hours. It is concluded that REG 1 is non-irritant to the eyes of the rabbit.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:

only one study available

Justification for selection of eye irritation endpoint:

only one 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).