Registration Dossier

Administrative data

Description of key information

In conclusion, the test substance 6,6’-di-tert-butyl-2,2’-methylendi-p-cresol (DBMC) showed a practically non-irritating potential to rabbit skin (Raschig AG 1995). A low eye irritation potential of the test substance was revealed in an eye irritation study with New Zealand White rabbits (Raschig AG 1995). 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study (OECD TG 404)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3 (2 males, 1 female)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
6
Reversibility:
other: no effcts
Remarks on result:
other: no effects

Very slight erythema (grad 1) was noted at one treated skin site at the 1-hour observation. No dermal reactions were noted at the 24, 48 and 72 -hours observations.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to EU labeling regulations

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.
Executive summary:

The test material, RALOX 46, produced a primary irritation of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effcts were noted.

The test material did not meet the critera for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study (OECD TG 405)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
once
Observation period (in vivo):
up to 72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: mean: animals and time points
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: mean: animals and time points
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects

Residual test material was noted around all treated eyes during the study.

No corneal effects were noted during the study.

Iridial inflammation was noted in two treated eyes at the 1 -hour observation.

Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1 -hour observation. Minimal irritation was apparent in two treated eyes at the 24 -hours observation. Treated eyes appeared normal 24 or 48 hours after treatment. No effects noted after 72 hours.

Maximum group mean score: of 14 1-hour after treatment (conjunctivae)

Maximum total score: 19 at 1 -hour after treatment (iris and conjunctivae) (remark: no effects on cornea)

The test material did not produce positive criteria in any rabbit according to EU labelling regulation.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not produce positive criteria in any rabbit according to EU labelling regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

Non-human information

The skin irritating potential of 6,6’-di-tert-butyl-2,2’-methylendi-p-cresol (DBMC) was evaluated in a GLP and guideline study (OECD TG 404) (Raschig AG 1995). Three New Zealand White rabbits were exposed under semi-occlusive conditions for four hours with 500 mg test substance, moistened with 0.5 ml distilled water. Approximately one hour following the removal of the test substance, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J. H. (1977). Very slight erythema (grad 1) was noted at one treated skin site at the 1-hour observation. No dermal reactions were noted at the 24, 48 and 72 -hour observations. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.

Human information

In an early study report with human volunteers no irritating effects were observed in 0/6 volunteers treated with 6,6’-di-tert-butyl-2,2’-methylendi-p-cresol (DBMC) (Kimmerle 1958).

Eye

Non-human information

The eye irritating potential of the test substance 6,6’-di-tert-butyl-2,2’-methylendi-p-cresol (DBMC) was evaluated in a GLP and guideline study (OECD TG 405) (Raschig AG 1995). Three New Zealand White rabbits were evaluated. One rabbit was initially treated. A volume of 0.1 ml of the test material (ca. 53 mg) was placed into the conjunctival sac of the right eye; the left eye remained untreated and was used for control purpose. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to Draize J., H. (1977). Residual test material was noted around all treated eyes during the study. No corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes at the 1-hour observation and was reversible within 24 hours. Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Minimal irritation was apparent in two treated eyes at the 24 -hours observation. Treated eyes appeared normal 24 or 48 hours after treatment. No effects noted after 72 hours. The test material did not produce positive criteria in any rabbit according to the EU labelling regulations.

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).