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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test item was not irritating to skin and eye.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 20 h occlusive treatment, 2 animals, 72 h scoring not performed)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 20h treatment duration, 72 h scoring not performed, 2 animals)
Principles of method if other than guideline:
BASF-test:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. Additionally, the substance was applied for 1, 5 and 15 minutes. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours, 5, 7 and 8 days after administration. Findings were graded as described in OECD test guideline 404.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.75 kg (male) and 3.41 kg (female)

ENVIRONMENTAL CONDITIONS: not reported


Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Concentration: 80% (in water)



Duration of treatment / exposure:
20 h
Observation period:
7 days
Number of animals:
2 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: with water (possibly containing mild detergent)
- Time after start of exposure: 20 h

SCORING SYSTEM: as described in OECD guideline 404 (the BASF-code from the raw data was converted into the Draize scheme.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: all timepoints
Score:
0
Max. score:
4
Reversibility:
other: no effects
Other effects:
Substance residues (light-blue) were noted in both animals at 24 h and 48 h after exposure and in animal 2 until day 6.
Interpretation of results:
not irritating
Remarks:
Migrated information
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 50 mg application amount, 2 animals, 72 h scoring not performed)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(reduced application amount, 72 h scoring not performed, 2 animals)
Principles of method if other than guideline:
BASF-test:
50 mg of the test substance were applied to the conjunctival sac of one eye of two white Vienna rabbits. Talcum powder was used as a control. Animals were observed for 8 days and skin changes were observed on working days. The substance was not washed out. Findings were graded as described in OECD test guideline 405.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.25 kg (male) and 3.16 kg (female)

ENVIRONMENTAL CONDITIONS: not reported
Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of each animal was treated with talcum (amorph)
Amount / concentration applied:
50 mg of test material (100%)
Duration of treatment / exposure:
Single exposure without washing of the eyes.
Observation period (in vivo):
8 days (Eyes were observed (after application): 10 min; 1, 3, 24, 48 hours and 4, 7 and 8 days)
Number of animals or in vitro replicates:
2 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: evaluation was carried out according to the Draize scoring system.

TOOL USED TO ASSESS SCORE: fluorescein at the end of the observation period
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Other effects:
Substance residues were seen until 3 h (animal #1) and until 24 h (animal #2) after application.
Weight of animal #1 and animal #2 at the end of the observation period was 3.07 kg and 3.23 kg, respectively.

The talcum-treated control eyes of the animals showed slight redness of the conjunctiva (Draize scoring system 1 of 3), which was fully reversible within 48 h in both animals. In the control eye of animal #2, chemosis score 1 (of 4) could be observed at 3 h after application, which was fully reversible within 24 h.

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In the key skin irritation study (BASF AG, 1976, equivalent to OECD 404) two rabbits were treated once with the test item via occlusive dermal exposure for 20 h. Animals were observed after 24h, 48h and at day 6 and 8 after exposure. Skin reactions were observed and scored according to the BASF scoring system which was converted into Draize Scores. Thereby animals showed an average edema scores of 1 and 1.5 (24h and 48h), which were fully reversed within the observation period. No other irritating effects were observed and thus the test item was classified as not irritating to skin.

Eye irritation

In the key eye irritation study (BASF AG, 1976, equivalent to OECD 405) two Vienna White rabbits were treated once with 50 mg of the test item by single exposure without washing of the eyes. The second eye of each animal was treated with talcum. Eye reactions were observed and scored according to Draize 10 min, 1 h, 3 h, 24 h, 48 h, and 4, 7 and 8 days after the start of treatment. One animal showed a mean conjunctivae score of 0.5 (time point: 24 -48h) which was fully reversible within 48 h. All other irritation parameters showed a score of 0 indicating that the test item was not irritating to the eyes under the conditions of the study.


Justification for selection of skin irritation / corrosion endpoint:
most reliable study

Justification for selection of eye irritation endpoint:
most reliable study

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).