Registration Dossier

Administrative data

Description of key information

A skin and an eye irritation study is available (BASF AG, 1967) which addresses both endpoints adequately.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation, substance tested only as 50% dilution, Observation/reading only at 24 hours and 8 days, only 2 animals tested
Principles of method if other than guideline:
The test substance was applied substance as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 2.8 kg
- sex: male

no further data
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Substance applied as a 50 % aqueous preparation (ca . 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of irritation were observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Remarks on result:
other: no signs of irritation were observed

- Systemic toxicity: No mortality occurred. There were no   signs of clinical toxicity from the dermal exposure.

- Irritation score: No skin findings were observed at any time 

- Summary: Occlusive application for 20 hrs to rabbit   skin did not lead to any signs of irritation.

Interpretation of results:
GHS criteria not met
Conclusions:
Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation, only 2 animals tested, only 50 µl applicated
Principles of method if other than guideline:
The test substance was applied as a single instillation (50 µl) as powder, the substance was not washed out, only 2 rabbits were used
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no further data
Vehicle:
unchanged (no vehicle)
Controls:
other: treated with talcum powder
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 microliter (50 mm3)
Duration of treatment / exposure:
single instillation of the test substance as powder, the substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
0.5
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1/2 animals score 0; 1/2 animals score 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48/72 hours
Score:
0

Summary:

The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.

Interpretation of results:
GHS criteria not met
Conclusions:
The mean score observed for redness of the conjunctivae is 0.167 ( for 24, 48 and 72 hours) which is below 2.5.
These finding were reversible within 48 hours.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In an older skin irritation study with 2 rabbits performed with ca. 0.5 g of a 50 % aqueous suspension of IBDU (purity ca. 90 - 96 %) under occlusive conditions for 20 hours, no local effects or other clinical signs were observed (reading time points: 24 hours and 8 days after application) (BASF AG, 1967).

 

Eye irritation

In an older eye irritation study with 2 rabbits performed with ca. 0.05 ml IBDU (purity ca. 90 -96%), slight redness (grade 1) was observed 24 hours after application in both animals. These findings were fully reversible within 48 hours (BASF AG, 1967).

 

Respiratory Tract

This information is not available  

Justification for classification or non-classification

No classification and labeling is required, as no skin irritation was observed and eye irritation was marginal as only slight redness was observed after 24 hours, which was fully reversible after 48 hours.