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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a primary skin and eye irritation study, no skin or eye irritating effects were observed in six New Zealand rabbits. (BASF, 1970)

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:
Dec. 1969 - Jan. 1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study. Scientifically acceptable study report.
Qualifier:
according to guideline
Guideline:
other: Hazardous Substances, Part 191, Section 10 and 11; FDA, Washington 1965
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and abraded
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Concentrations: 2500 and 10000 mg/kg bw as 50% suspension. One positive control group was tested.

Duration of treatment / exposure:
Refer to observation period. Skin sites were not washed after 24 hours with the semiocclusive dressing.
Observation period:
14 days
Number of animals:
3 animals/sex/dose
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: rubber sleeve

SCORING SYSTEM: According to Draize et al.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation regarding erythema and edema were observed either on the intact or on the abraded skin.
Interpretation of results:
not irritating
Remarks:
Migrated information
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study. Scientifically acceptable study report.
Qualifier:
according to guideline
Guideline:
other: Hazardous Substances, Part 191, section 12, FDA, Washington 1965
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
SIngle exposure. Eyes of the animals were not washed.
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Remarks on result:
other: No data on maximum score in the report.
Irritant / corrosive response data:
All animals showed no reactions of the conjunctivae or cornea. In the other parts of the eye no pathological findings could be discovered.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Following the experimental design according to Hazardous Substances, Part 191, Section 10 and 11; FDA, Washington 1965, the test substance was applied to the back of six New Zealand White rabbits (BASF, 1970). The skin sites were semiocclusively covered. The skin of half of the animals was abraded. The test animals were exposed to the test substance at concentrations of 2500 and 10000 mg/kg bw. Dressings were removed after 24 hours. The animals were observed for 14 days. Irritation was scored by the method of Draize. No skin irritation regarding erythema and edema were observed either on the intact or on the abraded skin.

In a human repeated insult patch test a pre test included the degree of irritation caused by the test substance (please refer to IUCLID section 7.10.4). 50 volunteers (22 males and 28 females) were occlusively exposed to the test substance and did not show any signs of erythema or edema of the treated skin site.

Eye irritation

Following the experimental design according to Hazardous Substances, Part 191, section 12, FDA, Washington 1965, 100 mg of the test substance were instilled into the left eye of 6 New Zealand White rabbits (3/sex) (BASF, 1970). The eyes were not washed. Animals were observed for 72 hours. All animals did not show any reactions of the conjunctivae or cornea. In the other parts of the eye no pathological findings could be discovered.


Justification for selection of skin irritation / corrosion endpoint:
Scientifically acceptable study report.

Justification for selection of eye irritation endpoint:
Scientifically acceptable study report.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled as eye or skin irritating under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled as eye or skin irritating under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014.