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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test material was not irritant on skin as well as mucous membranes of the rabbit eye

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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; Standard and non Standard test method, poor reporting and characterisation of test sample
Qualifier:
no guideline followed
Deviations:
not applicable
Remarks:
Barail Test using injection
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
5 animals employed
Principles of method if other than guideline:
Skin was shaved at the flanks of rabbits. 0.2 ml of a solution of the test material in sesame oil were injected intracutaneously at concentrations of 10, 5, 1, 0.1, 0.01, and 0.001 %. The pure vehicle served as a control.
In a second part of the study 0.5 ml of the highest concentrations (5 & 10 %) were applied epidermally on the intact skin and evaluated visually. This treatment was repeated on 5 consecutive days.
GLP compliance:
no
Remarks:
pre-dates GLP regulations
Species:
rabbit
Strain:
other: Yellow-Silver
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual cages
- Diet (e.g. ad libitum): Altromin ad lib.
- Water (e.g. ad libitum): no data
- Acclimation period: no dat

ENVIRONMENTAL CONDITIONS: no data
Type of coverage:
other: Part 1: injection; Part 2: open
Preparation of test site:
shaved
Vehicle:
other: sesame oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 0 - 0.001- 0.01 -0.1- 1- 5-10 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 ml
Duration of treatment / exposure:
no data
Observation period:
no data
Number of animals:
5
Irritation parameter:
other: visual inspection and expert judgment
Basis:
mean
Time point:
other: no data
Score:
0
Max. score:
0
Remarks on result:
other: No scores were reported
Irritant / corrosive response data:
Injection of 5 and 10 % induced erythema of the skin. Epidermal treatment caused no effects.
Other effects:
no
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material did no cause adverse reactions after epidermal application to the intact shaved skin of 5 rabbits.
Executive summary:

Five daily epidermal applications of 5 and 10 % solutions of the test material in sesame oil to the shaved skin of rabbits caused no adverse reactions.

Intradermal injection of the test material into the shaved skin of rabbits at 0.001 to 10 % in sesame oil caused only mild reactions at 5% and higher.

The test material is considered non irritant after topical application.

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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; no GLP; poor sample characterisation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
reduced observation period (24h)
GLP compliance:
no
Remarks:
predates GLP
Species:
rabbit
Strain:
other: Yellow Silver
Vehicle:
other: sesame oil
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 h; no washing reported
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
5
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1-3-7-24 h
Score:
0
Max. score:
0
Remarks on result:
other: visual inspection, no scores reported; as there were no signs of irritation the score was set at 0
Irritant / corrosive response data:
no irritation
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritant to the eyes of rabbits
Executive summary:

Eyes of five rabbits were exposed to 0.5 ml each of 5 and 10 % solutions of the test material. Effects were checked at 1, 3, 7 , and 24 hours after instillation.

No signs of irritation were detected at any time point.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test material was not irritant on skin as well as mucous membranes of the rabbit eye. Although studies are quite old and not performed to todays standards, observations were reliably reported.


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

Justification for selection of eye irritation endpoint:
only available study

Justification for classification or non-classification

As no effects were observed in any study. No classification is warranted.