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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
Juli 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd
- Age at study initiation:
- Weight at study initiation: 2.7 to 3.3 kg
- Housing: single
- Diet (ad libitum): ssniff K4, Versuchsdiäten GmbH, Soest
- Water (ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 45 to 65
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: July 1986
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
to moisture the test substance to provide contact with the skin
Controls:
yes, concurrent vehicle
Amount / concentration applied:
500 mg pasted test substance evenly distributed over 6 cm²
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: -
- Type of wrap if used: Hansamed Wundpflaster Hypoallergen (Beiersdorf No 2342); Fixomull-Strech Klebevlies (Beiersdorf No 2039)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 3
Time point:
other: all
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1,2,3
Time point:
other: all
Score:
0
Max. score:
4
Irritant / corrosive response data:
No effects observed
Other effects:
-
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to skin
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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study non-GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd
- Age at study initiation: -
- Weight at study initiation: 3.3 to 3.5 kg
- Housing: single
- Diet (ad libitum): ssniff K4, Versuchsdiäten GmbH, Soest
- Water (ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 45 to 65
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: July 1986
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 µL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): NaCl-solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp + fluorescein + UV-light
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3
Time point:
other: all
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
other: all
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal #1
Time point:
other: 24-72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal: #2 and #3
Time point:
other: 24-72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
other: 24-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No effects were seen on day 14. Therefore, no evaluation was done on day 21
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slightly irritating according to study report.
Not irritating according to Regulation (EC) No 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification