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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14.11.00 - 21.11.00
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually housed in labelled cages with perforated floors and equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet, 100 gr. per day
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 days before the treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+-3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals of one sex
Details on study design:
TEST SITE
- Area of exposure: 150 square centimeters

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours and 24 minutes


Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: hours
Score:
24 - 72
Max. score:
1.3
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: hours
Score:
24 - 72
Max. score:
1.3
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: hours
Score:
24 - 72
Max. score:
1.3
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: hours
Score:
24 - 72
Max. score:
0.7
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: hours
Score:
24 - 72
Max. score:
0.7
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: hours
Score:
24 - 72
Max. score:
1.07
Reversibility:
fully reversible
Remarks:
within 7 days

INDIVIDUAL SKIN IRRITATION SCORE:

 Animal #        1        2        3
 Time after exposure  Erythema  Edema  Comments Erythema  Edema  Comments  Erythema  Edema  Comments
 1 hour  Well defined  No edema  -  Well defined  No edema  -  Well defined  No edema  -
 24 hours  Well defined  Very slight  -  Well defined Very slight  -  Well defined  Very slight  -
 48 hours  Very slight  Very slight  -  Very slight  Very slight  -  Very slight  Very slight  -
 72 hours  Very slight  No edema  r  Very slight  No edema  l  Very slight  No edema l,r 
 7 days  No erythema  No edema l   No erythema  No edema l   No erythema  No edema l 

r: Erythema at the edges of the application-area

l: Scaliness

ANIMAL SPECIFICATIONS:

 Animal n° Sex   Age (weeks)  Body weight (gr)
 1  Male  7 -9  1488
 2  Male  7 -9  1529
 3  Male  7 -9  1545
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.09.2009 - 28.10.2009
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
other: INVITTOX. 1992. Protocol No. 47: HET-CAM Test
Deviations:
no
Principles of method if other than guideline:
To determine the potential irritancy using an alternative to the Draize methodology. The methodology was based on that described in INVITTOX. 1992. Protocol No. 47: HET-CAM Test.
GLP compliance:
yes (incl. QA statement)
Species:
other: Hen's eggs (white Leghorn)
Vehicle:
other: Mazola Corn Oil
Controls:
yes
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Continuously for 5 minutes
Number of animals or in vitro replicates:
24 eggs
Irritation parameter:
other: Classification of the irritating potential is according with the table on page 7 of the attached full study report
Basis:
other: See page 6 and 7 of the report
Time point:
other: 1 and 5 minutes after exposure
Score:
> 1 - < 5
Max. score:
21
Reversibility:
other: Not applicable
Interpretation of results:
other: None to slight
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the threshold concentration of greater than 10% and the IS10% of 0, the irritating potential of CBE was determined as none to slight.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on eye irritation: irritating

Justification for classification or non-classification