Registration Dossier

Administrative data

Description of key information

The test substance was evalueted for its irritant effects on skin and eyes on Albino Rabbits.

The primary skin irritation index was calculated to be 1 and all the effects were completely reversible after 72h.

The primary eye irritation index was calculated to be 1.33 for the rinsed test animals and all the effects were completely reversible after 72h.

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:
November 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The skin of the tested animals was abraded and epidermal incisions were made prior to the application of the substance and the exposition lasted for 24 hours.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Each rabbit was sexed, weighted and ear tagged. The weight ranged from 2.25kg to 2.55kg. The rabbits were quarantined and acclimated to laboratory conditions for 12 days. The animals were individually housed in steel wire-bottomed cages, suspended above the droppings. Animals were observed twice daily during the quarantine period.
Type of coverage:
occlusive
Preparation of test site:
other: On each rabbit, two test sites were only clipped, the other two were also abraded.
Remarks:
24 hours prior to the dermal application an Oster small animal electric clipper was used on the backs of the animals.The clipped area was about 10% of the total body surface area.
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
0.5g of the test material was slightly moistened with physiological saline and applied to each of the test sites with a small plastic weight boat
Duration of treatment / exposure:
24h exposure
Observation period:
4 days
Number of animals:
6
Details on study design:
Six animals (3 males and 3 females) were selected after the quarantine period and weighted: the weight ranged from 2.25kg to 2.55kg.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary irritation index was calculated to be 1.
Other effects:
No other effects were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritant for skin.
Executive summary:

The primary skin irritation index was calculated to be 1 and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for 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:
supporting study
Study period:
November 1981
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
eye rinsed after 30sec instead of 1 hour and not all the required data are given in the test report.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The eyes of the tested animals were rinsed after 30 seconds instead of 1 hour.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Each rabbit was sexed, weighted and ear tagged with a unique animal numer (weight range: 1.95 kg to 2.55kg). The rabbts were quarantined and acclimated to laboratory conditions for 12 days prior to initiation of the study. The rabbits were individually housed in stain-less steel wire-bottomed cages suspended above the droppings. Animals were observed twice daily during the quarantine period.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100mg applied to the right eye - 6 not rinsed and 3 rinsed after 30 seconds
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 animals (4 males and 5 females)
Details on study design:
Grading for irrittation and injury were made at 24, 48 and 72 hours and at 4 and 7 days, using the standard scoring system of Draize. Fluoroscein examinations were used to facilitate evaluation of potential corneal damage.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 h - 4d - 7d
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 72h for rinsed animals - 7 days for not rinsed animals
Irritant / corrosive response data:
The primary irritation index was calculated to be 4.0 for the not rinsed test animals and 1.33 for the rinsed test animals.
Other effects:
no signs of systemic toxicity and no deaths occurred
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritant for eyes.
Executive summary:

The primary eye irritation index was calculated to be 1.33 for the rinsed test animals and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for eyes.

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

Additional information

Justification for classification or non-classification

The primary skin irritation index was calculated to be 1 and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for skin.

The primary eye irritation index was calculated to be 1.33 for the rinsed test animals and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for eyes.