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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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


After dermal as well as ocular exposure in vivo only very slight or no adverse effects were 



  

detected.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP, short report giving the relevant details of procedure and results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission of the U ,S .A. in The Code of Federal Regulations, Title 16, Section 1500, 41,
GLP compliance:
no
Remarks:
pre-dates GLP regulations
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/site
- Concentration (paste): 50 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 0,5 mL
- Concentration (paste): 50 %
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 square inch (6,2 cm²)

- Type of wrap if used: surgical gauze and inpervious cover

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure:24, 48, 72 hours

Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all observatin times
Score:
0
Max. score:
0
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not irritant on the skin of 6 rabbits after 24 hours occlusive exposure.
Executive summary:

The procedure employed was that prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 41.

On this occasion 0.5 g of the test item were mixed with 0.5 ml of distilled water before application to the skin. The treated site was then covered with an occlusive wrap for 24 hours. Observations were made 24, 48 and 72 hours after the start of treatment.

RESULTS

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

CONCLUSION

The test item is considered to be "non-irritant" to rabbit 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:
disregarded due to major methodological deficiencies
Study period:
1975
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: early study, short report, no analytical data, conflicting information in the report (differences between text and table)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500,42
GLP compliance:
no
Remarks:
pre-dates GLP Regulation
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.1 ml


VEHICLE
- Amount(s) applied (volume or weight with unit): none
Duration of treatment / exposure:
no termination of exposure; eyes were not washed
Observation period (in vivo):
Observations were made at 24, 48 and 72 hours after start of exposure
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: according to:
Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, published by the Food and Drug Officials of the United States,, 1959
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: This was the only finding in this study
Irritant / corrosive response data:
Only 1 of 6 animals showed slight redness of the conjunctiva at 24 h after treatment. No other findings were recorded in any animal.
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be "non-irritant" to the rabbit eye.
Executive summary:

The procedure ernployed was that prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500,42.

On this occasion 43 mg of the unchanged test item were instilled into one eye of each of 6 rabbits, the other eye remaining untreated served as a control. The ocular reactions were scored 24 , 48 and 72 hours after treatment by the method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p51, 1959.

RESULT

Mild conjunctival reactions only were observed in one animal. The other animals did not show any observable response to treatment throughout the 7 days observation period,

Mean Draize score at day 1 = 0.3

CAVE: The text of the report give results different from the table in this report!

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

As no relevant adverse effects were detected in vivo in rabbits after dermal as well as ocular exposure.


Justification for selection of skin irritation / corrosion endpoint:
Only available study

Justification for selection of eye irritation endpoint:
only available in vivo study supported by evidence from an in vitro (BCOP) result

Justification for classification or non-classification

No classification, as no relevant adverse effects were detected after dermal as well as ocular exposure.