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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Non irritant

Eye Irritation/Corrosion

Non irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 02, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The endpoint was evaluated by means of Read Across approach. THe complete justification is attached at section 13. The reliability of the source study report is 2. Further information was attached at section 13
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.11 (February 1965).
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.90 Kgs. (♂) and 2.21 Kgs. (♀)
- Housing: semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxbid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C. (± 1°)
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution):10g. of the test compound was mixed with 10ml. of water to make a solution of 15ml. 0.75ml. of which was applied to each test site
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
4 males and 2 females
Details on study design:
TEST SITE
- Area of exposure: the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded
- Type of wrap if used: The area were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 13
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 15
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 12
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 14
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 16
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 13
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 12
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 14
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 16
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant.
Executive summary:

Method

The substance was tested for skin rabbit according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous .Substances Labelling Act Sect. 191.11 (February 1965). Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the midline of the back were used on each rabbit. The left hand site remained intact.

Results

Slight erythema and very slight to slight oedema were seen in 4/6 and 5/6 rabbits respectively 24 hours after application of the compound. All sites were normal by 72 hours.

Conclusion

Non irritant

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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 02, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Remarks:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.90 Kgs. (♂) and 2.21 Kgs. (♀)
- Housing: single housed in semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxbid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C. (± 1°)
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg
Duration of treatment / exposure:
single instillation into the conjunctival sac
Observation period (in vivo):
1, 6, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
2 females and 4 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
Irritation parameter:
conjunctivae score
Basis:
animal: 11
Time point:
other: 24, 48, 72 hours
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 13
Time point:
other: 24, 48, 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 12
Time point:
other: 24, 48, 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible
Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant.
Executive summary:

Method

The substance was tested for eye irritation according to "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965).

Results

The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. . The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute. The rabbits were examined 1, 6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. A slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. All eyes were normal by 48 hours (washed) and 72 hours (unwashed).

Results

Non irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

The substance is not classified a skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.

EYE IRRITATION

The substance does not meet the requirements to be classified.