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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin
rabbit, 4 h, semiocclusive: not irritating (GLP, OECD 404; BASF 1991)


Eye
rabbit, 0.1 mL, not rinsed: not irritating (GLP, OECD 405; BASF 1991)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study is available from the original notifier since the substance was notified under NONS.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.44 kg (male), 3.17-3.51 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
Application of 0.5 ml of the test substance (cooled down to body temperature) to the test patch (2.5 cm x 2.5 cm)
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3
Details on study design:
Clipping of the fur: at least 15 hours before the beginning of the study.
Application site: upper third of the back or flanks
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h, 8 d and 15 d after beginning of application; scoring according to the OECD/Draize system
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: scaling observed on 1/3 animals at the 15d reading; see table below for details
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: scaling observed at the end of the observation period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Substance shows only minor skin irritating capacity. Therefore, classification according to 67/548/EEC and UN-GHS is not warranted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo study is available from the original notifier since the substance was notified under NONS
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.22 kg (male), 3.28-3.96 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml of the test substance cooled down to body temperature
Duration of treatment / exposure:
Single application; the substance was not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Readings: 1 h, 24 h, 28 h, 72 h after application
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:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 -72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Other effects:
Slight to moderate discharge was observed in 2 of the three tested animals which reversed fully within 72 h.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

In a primary dermal irritation study according to OECD test guideline 404 and following GLP requirements, three White Vienna rabbits were dermally exposed to 0.5 mL of unchanged Keroflux ES 3241 (purity not reported) for four hours to 2.5*2.5 cm of intact skin under semiocclusive conditions (BASF AG 1991). Animals then were observed for 15 days. Irritation was scored by the OECD/Draize method. Mean erythema and edema scores of the relevant 24, 48 and 72 h readings were 1.2 and 0.0; erythema were reversible at most within 15 d. Scaling was observed in 1 of 3 animals at the final reading. Keroflux ES 3241 is therefore not considered as a skin irritant.

Eye

In a primary eye irritation study according to OECD test guideline 405 and following GLP requirements, 0.1 mL of unchanged Keroflux ES 3241 (purity not reported) was instilled into the conjunctival sac of the left eye of three White Vienna rabbits (BASF AG 1991). The eyes were not washed out. Animals then were observed for three days until all observed effects were resolved. Irritation was scored by the OECD/Draize method. Mean scores for cornea opacity, iritis, conjunctivae redness and chemosis were 0, 0, 0.6 and 0 for the relevant readings 24, 48 and 72 hours after instillation. Slight conjunctivae redness was reversible within at most 72 h.Keroflux ES 3241 is therefore not considered to be an eye irritant.

Justification for classification or non-classification

According to the conditions and results of the available tests, substance is not classified as skin and eye irritant according to 67/548/EEC and UN-GHS, respectively.