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Diss Factsheets

Administrative data

Description of key information

Skin irritation (Rat, GLP): not skin irritating [Schering AG, Report No. X323 -draft-, 1998-11-05]



Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating [Schering AG, Report No. X344 -draft-, 1998-12-23]

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:
supporting study
Study period:
July 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.4-0.9 ml) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Preparation of test site:
not specified
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3/sex
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was tolerated without any local skin irritations.
Executive summary:

The single dermal administration of Dimethylenketon to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The test substance was tolerated without any local skin irritations.

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
Study period:
October 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02-24
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Controls:
other: left eye served as control
Duration of treatment / exposure:
test substance remained in the eye and eye was not rinsed
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
2 males and 2 females
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 72 hours

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1 (male)  Corneal Opacity 0 0.0
   Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
   Conjunctivae (reddening) 2 1 1 1.3
   Conjunctivae (swelling) 1 1 0 0.7
 2 (male)  Corneal Opacity 0 0 0 0.0
   Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
    Conjunctivae (reddening) 1 0 0 0.3
    Conjunctivae (swelling) 0 0 0 0.0
 3 (female)   Corneal Opacity 0 0 0 0.0
    Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
    Conjunctivae (reddening) 1 1 0 0.7
    Conjunctivae (swelling) 0 0 0 0.0
 4 (female)   Corneal Opacity 0 0 0 0.0
    Iris (redness, swelling, reaction of pupillary reflex etc.)  0 0 0 0.0
    Conjunctivae (reddening) 1 0 0 0.3
    Conjunctivae (swelling) 0 0 0 0.0

Injection of blood vessels in the iris were seen in one animal and slight to moderate reddening and slight swelling of the conjunctivae in all animals until 24 hours after administration. On day 5 (96 hours after administration) all animals were without findings.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritating to the eye.
Executive summary:

The single administration of Dimethylenketon into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 28.1 -37.4 mg) results in an injection of blood vessels in the iris in one animal and slight to moderate reddening and slight swelling of the conjunctivae in all animals until 24 h after administration. On days 3 and 4 (48 and 72 h after administration) only slight conjunctival reddening and/or swelling was seen in two out of four animals and on day 5, all animals were without findings. According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris, 0.2 for conjuntival swelling and 0.7 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The single dermal administration of Dimethylenketon to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.

Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Dimethylenketon can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.

The single administration of Dimethylenketon into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 28.1 -37.4 mg) results in an injection of blood vessels in the iris in one animal and slight to moderate reddening and slight swelling of the conjunctivae in all animals until 24 h after administration. On days 3 and 4 (48 and 72 h after administration) only slight conjunctival reddening and/or swelling was seen in two out of four animals and on day 5, all animals were without findings. According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris, 0.2 for conjuntival swelling and 0.7 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.