Registration Dossier

Administrative data

Description of key information

 The test material was not irritating in vivo on rabbit skin as well as mucous membranes of rabbit eyes.. 

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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test material information:
Composition 1
Species:
rabbit
Strain:
other: white Wiener
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BASF
- Age at study initiation: no data
- Weight at study initiation: 2,3 kg (mean)

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 - 2 g/ animal
- Concentration (suspesion): 50 %

Duration of treatment / exposure:
20 h
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²

- Type of wrap if used: semi-occlusve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Irritation parameter:
other: No numbers were given
Remarks on result:
other: In 3 of 4 animals very slight to slight reddening was observed
Irritant / corrosive response data:
In 3 of 4 animals very slight to slight, transient reddening was observed 24 h after treatment
Other effects:
Blue discoloration by the substance
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material not irritant after semi-occlusive treatment of rabbit skin for 20 hours.
Executive summary:

The skin irritation hazard was tested in rabbits by semi-occlusive application of the test material for 20 hours. Animals were treated with a 50% aqueous paste. Observations werer made after 1, 5 oand 15 minutes of contact to the skin. Afterwards animals were treated for 20 hours.

After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbits. Additionally the skin was blue discolored by the test material.

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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test material information:
Composition 1
Species:
rabbit
Strain:
other: White Wiener
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BASF

- Weight at study initiation: ca. 2,3 kg ( mean)

- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
Vehicle:
water
Controls:
not required
Amount / concentration applied:
ca 50 mg
50% paste
Duration of treatment / exposure:
not limitd (no washing)
Observation period (in vivo):
8 days.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
no

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: verbal report, no numbers given
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
other: verbal report, no numbers given
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 and 24 h
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: slight reddening was reported, no number given
Irritant / corrosive response data:
Slight reddening of the conjunctivae was observed at 1 and 24 Hours after treatment.
Other effects:
no other effects occurred.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritant or corrosive on the eyes of two rabbits.
Executive summary:

Application of 50 mg/ animal on one eye of each rabbit caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation hazard was tested in rabbits by semi-occlusive application of the test material for 20 hours. Animals were treated with a 50% aqueous paste. Observations werer made after 1, 5 oand 15 minutes of contact to the skin. Afterwards animals were treated for 20 hours.

After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbits. Additionally the skin was blue discolored by the test material.

Application of 50 mg/ animal on one eye each of several rabbits caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.


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

not classified;

Skin:

After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbit

Eye:

Application of 50 mg/ animal on one eye each of several rabbits caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.