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Administrative data

Description of key information

Skin irritation (rat): not irritating [Draft report, Kurth 1996]
Eye irritation (rabbit): not irritating [Draft report, Treher & Kurth 1996]

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:
from June to July 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
Species:
rat
Strain:
other: Han:WST (SPF)
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 900 mg NaCl ad 100 ml bidist. water
Controls:
other: the untreated skin served as control
Amount / concentration applied:
218-240 mg/male animal or 192-214 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females

No local intolerance reactions at the application sites were observed (no scores documented)

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion.A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.

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:
August 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- 4 instead of 3 animals
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL (corresponded to 64-73 mg substance)
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2 males and 2 females
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Table 1: Results of the study

    

 Irritant effects (score)         

Animal no. (sex)

 Irritation parameter

24 h 48 h  72 h  Mean scores

 1 (M)

 Cornea

0 0.0
 

 Iris

0 0 0 0.0
 

 Conjunctiva (reddening)

1 0 0 0.33
 

 Conjunctiva (swelling)

0 0 0 0.0

 2 (M)

 Cornea

0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.66
   Conjunctiva (swelling) 0 0 0 0.0

 3 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 0 0 0.33
   Conjunctiva (swelling) 0 0 0 0.00

 4 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.66
   Conjunctiva (swelling) 0 0 0 0.00

The control eyes were without findings.

The single administration of 0.1 mL test substance (64- 73 mg ZK 47568) into the conjunctival sac of the right eye led in 4 of the 4 rabbits to slight transient reddening of the conjunctivae .

Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight transient irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight transient irritation.


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 or Regulation (EC) No. 1272/2008 (CLP) is not required.