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Description of key information

The hazard is derived from an analogue substance that contains all relevant structural features related to reactvity and pH. The lower purity of the test substance is considered acceptable since the effects were clearly below the thresholds of classification and labelling for the next higher hazard class. The target substance is considered to be not irritating to skin and irritating to eyes (GHS Cat 2A).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished report, Test itm purity less than 80%., fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24 2000
GLP compliance:
yes (incl. QA statement)
Remarks:
Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 6 - 7 months
- Weight at study initiation: 3.76 - 3.91 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung ("GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
minimally moistened
Controls:
other: untreated skin of the animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g (ca 0.3g adjusted for purity)
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation of skin reactions is performed according to the quoted guidelines.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Moderate erythema (grade 2) was observed in all animals immediately after removal of the patch. Slight erythema (grade 1) persisted in 2 animals up to 1 hour and in 1 animal up to 24 hours after removal of the patch.
- No other cutaneous reactions were observed during the study.
- The cutaneous reactions were reversible in 2 animals within 24 hours and in 1 animal within 48 hours after removal of the patch.
- Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0 for edema.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study, available as unpublished report, restrictions in design/reporting but adequate for assessment.Test itm purity less than 80%.
Qualifier:
no guideline available
Principles of method if other than guideline:
HET-CAM in vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs).
GLP compliance:
no
Species:
other: chorioallantoic membrane of fertilized hen eggs
Duration of treatment / exposure:
3 and 5 minutes
Number of animals or in vitro replicates:
3 eggs
Details on study design:
Tested irritation parameters were haemorrhagia and coagulaton. Time (seconds) of appearance as well as grading of effects (0-3) were noted.
Irritation parameter:
other: appearance of coagulation
Basis:
mean
Time point:
other: 180 and 300 sec
Score:
0
Remarks on result:
other: No coagulation occurred
Irritation parameter:
other: appearance of haemorrhagia
Basis:
mean
Time point:
other: 180 and 300 sec
Score:
0
Remarks on result:
other: No haemorrhagia occurred
Interpretation of results:
other: not corrosive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on eye irritation: irritating

Justification for classification or non-classification