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Description of key information

Based on a study of dermal irritation/corrosion on rabbit skin, the substance can be considered corrosive.

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:
The study was performed between 26 September 1995 and 10 October 1995 report issued 4th December 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to guidelines and under GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h after removal of patches. Additional observations day 7 and 14 to determine reverability of skin reactions
Number of animals:
3 animals
Details on study design:
On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact
epidermis by gross observation were selected for the study.

On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm
x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape
(BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an
elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
and scored according to the following scale from Draize J.H., (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the
Toxicity of Household Substances, National Academy of Sciences, Washington D.C. p.31.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Individual scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Reversibility:
not fully reversible within:
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Accurate scores could not be determined due to scabbing and scar formation
Remarks:
One of three rabbits showing much more extreme response preventing mean score being calculated
Irritant / corrosive response data:
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced reactions indicative of dermal corrosion at one treated skin site. The reactions included moderate to severe erythema, severe oedema and scabbing, Well-defined erythema, moderate oedema and crust formation were noted at the two remaining treated skin sites. Glossy skin and/or reduced regrowth of fur were noted at these two treated skin sites at the 14-day observation

Individual Scores - Rabbit Number and Sex
Skin reaction Observation time Female no 43 Female no 46 Male no 47
Ertythema/Eschar formation 1 h 3 Hd 2 2
24 h ?e St 2 2
48 h ?e St 2 2
72 h ?e St 2 2
 7 days ?e Su ?e Cf ?e Cf
14 days ?e Su Sd Sc 0 Fr G 0 Fr
Oedema Formation 1 h 4 2 2
24 h ?Od 3 2
48 h ?Od 3 2
72 h ?Od 3 3
 7 days ?Od ?Od ?Od
14 days ?Od 0 0

Cf - crust formation
Fr - reduced regrowth of fur
G - glossy skin
Hd - haemorrhage of the dermal capillaries
Sc - scar tissue
Sd - scab lifting to reveal further deep scabbing
St - dark brown/black-coloured scab
Su - sunken scab
?e - skin reactions prevented accurate evaluation of erythema
?Od - skin reactions prevented accurate evaluation of oedema
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, BEROLAMINE 20 was classified as CORROSIVE to rabbit skin. Corrosive effects were noted in one animal.

The test material classified as CORROSIVE to rabbit skin according to the EU labelling regulations. The symbol "C" and risk phrase R 34 "CAUSES BURNS" are therefore required.

Only results from a 4h application is available. The EU classification scheme in place when this study was completed, has now been replaced with Regulation (EC) No 1272/2008 on the classification and packaging of substances and mixtures. (CLP/GHs). Based on the results following the Substance should be classified as at least Corrosive Cat 1C.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

2. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced reactions indicative of dermal corrosion at one treated skin site. The reactions included moderate to severe erythema, severe oedema and scabbing, Well-defined erythema, moderate oedema and crust formation were noted at the two remaining treated skin sites. Glossy skin and/or reduced regrowth of fur were noted

at these two treated skin sites at the 14-day observation.

3. The test material was classified as corrosive to rabbit skin. Corrosive effects were noted in one animal.

The test material was also classified as corrosive according to EU labelling regulations.

The symbol "C" and risk phrase R 34 "CAUSES BURNS" are therefore required.

The EU classification scheme in place when this study was completed, has now been replaced with Regulation (EC) No 1272/2008 on the classification and packaging of substances and mixtures. (CLP/GHs). Based on the results following the  Substance should be classified as at least Corrosive Cat 1C.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on skin irritation/corrosion: corrosive

Based on the corrosive effects in skin, eye irritation tetsing is not ethical or scientifically required. It is assumed that the tets substance will also be corrosive to eyes.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The substance should be classified as corrosive to skin Cat 1C and Category 1 for serious eye damage.