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Diss Factsheets

Administrative data

Description of key information

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 404 nad 405.

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:
August 27, 1991 - December 6, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch: E828954
Storage: Tightly closed, dar, at room temperature (15 to 25°C)

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 23-24 weeks
- Weight at study initiation: 3.44 - 3.58 kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23°C
- Humidity (%): 44 - 81%


IN-LIFE DATES: From: day 1 To: day 8
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left side of the animal back (Test item), right side of the animal back (Carrier)
- Type of wrap if used: ployethylene foil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
Evaluation of skin reactions according to OECD 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin irritating potential could be detected.

Study design

To test for primary skin irritation, 0.5g of the test material was mixed with some drops of liquid paraffin to ensure good contact to the skin. Afterwards, the test material was spread onto 4 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under occlusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for further 7 days.

Results

In the primary skin irritation test no signs of primary irritation were observed early in the observation period. On day 5 and 6 of the study, two rabbits showed scales. The cumulative mean scores for erythema and edema were zero on days 1, 2 and 3.

Conclusions

According to the results of the study, for regulatory purposes the test material has to be classified as non-irritant for the skin.

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritating potential could be detected.
Executive summary:

This study was performed according to GLP and methods applied are fully compliant with OECD TG 404.

According to the results of the study, for regulatory purposes the test material has to be classified as non-irritant for the skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 27, 1991 - December 6, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD 1981, updated Guideline adopted Februaty 24, 1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch: E828954
Released until: July 1, 1993

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 23-24 weeks
- Weight at study initiation: 3.44 - 3.58 kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamo; type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23 °C
- Humidity (%): 44 to 81 %.
- Air changes (per hr): --

IN-LIFE DATES: From: day 1 To: day 8
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g per animal
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 8 of the experimental part
Number of animals or in vitro replicates:
2 male & 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according OECD-Guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in 2 animals, and in 1 animal discharge (score 1) at the first reading. Later on no abnormalities were seen.
Other effects:
none

Study design

To test for primary eye irritation, the test material was instilled into the conjunctival say of rabbits. The first examination of the treated eye followed 1 hour after instillation. The examinations were performed daily for further 7 days.

Results

In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in 2 animals, and in 1 animal discharge (score 1) at the first reading. Later on no abnormalities were seen.


Conclusion

According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.

Interpretation of results:
GHS criteria not met
Conclusions:
According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.
Executive summary:

The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.


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

Based on the provided information there is no need to classified according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.