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Administrative data

Description of key information

Skin irritation (rat): not irritating [Draft report, Kurth 1994]
Eye irritation (rabbit): not irritating [Draft report, Schöbel 1994]

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 July to August
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
Reference:
Composition 0
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
Test material information:
Composition 1
Species:
rat
Strain:
other: HAN: WIST (SPF)
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 0.9 % (w/v) NaCl-solution
Controls:
other: the untreated skin served as control
Amount / concentration applied:
234 -264 mg/male animal or 190 - 204 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females

The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Executive summary:

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. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

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 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
10 mg
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
6 days
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:
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:
0.11
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 (F)

 Cornea

0 0.0
 

 Iris

0 0 0 0.0
 

 Conjunctiva (reddening)

0 0 0 0.0
 

 Conjunctiva (swelling)

0 0 0 0.0

 2 (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 0.0

 3 (F)

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

The control eyes were without findings.

Local findings in all animals after treatment with the test substance on application day were: slight to moderate secretions, slight reddenings and vessel injections of the conjunctivae and slight to moderate swellings of the conjunctivae (2 animals). The single administration of 100 mg test substance into the conjunctival sac of the right eye led in 1 rabbit to slight reddening of the conjunctivae 24 h after application.

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 in 1 out of 3 rabbits. The findings were fully reversible by day 2 after administration. TAccording to EU classification criteria the test substance need not be labelled as an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 (Kurth, 1994). The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

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 in 1 out of 3 rabbits (Schöbel, 1994). The findings were fully reversible by day 2 after administration.According to EU classification criteria the test substance need not be labelled as an eye irritant.


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.