Registration Dossier

Administrative data

Description of key information

Skin irritation in vivo (Rabbit-NZW, GLP, OECD TG 404): not irritating to the skin
[Bayer AG, Report No. PH-18456, 1989-10-23]
Eye irritation in vivo (Rabbit-NZW, GLP, OECD TG 405): not irritating to the eye
[Bayer AG, Report No. PH-18456, 1989-10-23]

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:
other information
Study period:
July 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 405
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0

Results of the study:

  Irritant Effects (Scores)
  24 h   48 h      72 h         Mean scores
 animal   erythema   edema   erythema   edema   erythema   edema   erythema  edema 
 1
 2 0 0
 3 0
Executive summary:

500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.

In this skin irritation study N-Formylaminosorbit was not irritating to 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
Type of information:
experimental study
Adequacy of study:
other information
Study period:
July 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 404
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 females
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Results of the study

      Irritant Effects (Score)              
 Animal    1 h 24 h   48 h  72 h  7 d   Mean scores
 1 Cornea Opacity 0 0 0  0.0
  Cornea Area 0 0 0 0 0   
  Fluorescein Intensity - 0 - - -  
  Fluorescein Area - 0 - -  
  Iris 0 0
  Conjunctivae Redness 0 0  0.0
Conjunctivae Swelling 0  0.0
  Aqueous humour 0 0 0 0 0  
  Discharge 1 0 0 0 0  
 2 Cornea Opacity 0 0 0.0 
  Cornea Area 0 0 0 0 0
  Fluorescein Intensity - 0 - -  
  Fluorescein Area  - 0 - -  
  Iris  0 0 0 0 0 0.0 
  Conjunctivae Redness 0 0 0 0 0.0 
  Conjunctivae Swelling 0 0 0.0 
  Aqueous humour 0 0  
  Discharge 1 0  
 3 Cornea Opacity 0 0 0.0 
  Cornea Area 0 0
  Fluorescein Intensity -  
  Fluorescein Area -  
  Iris 0 0 0.0 
  Conjunctivae Redness 0 0 0.0 
  Conjunctivae Swelling 0 0 0.0 
  Aqueous humor 0 0  
  Discharge 1 0  
Executive summary:

100 mg of the test substance was administered into the conjunctival sac of one eye of female rabbits with rinsing 24 h after instillation.

Evaluation of eye irritation was made according to Draize.

According to the classification criteria N-Formylaminosorbit is not irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the skin irritation test in all 3 animals no signs of skin irritation could be observed.

In the eye irritation test discharge (grade 1) 1 h after instillation was the only finding in all 3 animals. No signs of eye irritation could be observed after 24, 48 and 72 h.


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

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.