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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Referenceopen allclose all

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
mouse
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 %
Duration of treatment / exposure:
Twice a day for 14 days
Observation period:
14 days
Irritation parameter:
other: histopatological observation
Basis:
mean
Time point:
14 d
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
other: Homo sapiens sapiens
Strain:
not specified
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Irritation parameter:
other: observations
Basis:
mean
Time point:
24 h
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100%
Duration of treatment / exposure:
1 day
Observation period:
1 day
Irritation parameter:
other: histopatological observation
Basis:
mean
Time point:
24 h
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
other: Homo Sapiens Sapiens
Strain:
not specified
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100%
Duration of treatment / exposure:
20 days
Observation period:
34 days
Number of animals:
20
Details on study design:
TEST SITE
- Area of exposure: skin
- % coverage:
- Type of wrap if used: Beiersdorf-Testpflaster


OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 12 hours

Irritation parameter:
other: observation
Basis:
mean
Time point:
21 d
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Other effects:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
no irritation observed
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Rabbit eye - the product is tolerated without any reaction of the eye.
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Irritation parameter:
other: observation
Basis:
animal:
Time point:
other: not mentioned
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
DIBA is without reaction when applied an the eye of rabbit.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification