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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: not irritating 
eye irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
skin irritation / corrosion
Data waiving:
other justification
Justification for data waiving:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 18th 1980 to December the 12th 1980
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
equivalent or similar to guideline
other: The procedure followed was a modification of that desribed by Draize
GLP compliance:
not specified
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: not stated
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimitised at least 3 days prior to test initiation

- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness

IN-LIFE DATES: From Day 0 To: End of study
not specified
other: yes, the other eye was used for control purposes
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1ml

Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Details on study design:
- Washing (if done): If any of the test article remained in the eye for 24 hours, the eye was washed out with lukewarm water after the 24 hour reading.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

Irritation parameter:
overall irritation score
for all animals
Time point:
other: 24, 48 and 72 hours
Max. score:
fully reversible within: 1 hour
Irritant / corrosive response data:
The test material showed no effects to either the cornea, iris or conjuctivae.
Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
The test substance is not an occular irritant to rabbits under the conditions of the test.
Executive summary:

The test substance is not an occular irritant to rabbits under the conditions of the test.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a non-standard skin irritation study, six rabbits each received a single dermal application of 0.5 mL of the test substance (mixed as a 50% gravimetric mineral oil suspension) on two test sites, one abraded and one intact (Cade, 1980). The test substance was covered with a surgical gauze pad and the entire trunk of each animal was encased in an impermeable occlusive wrapping fixed in place with adhesive tape. The wrapping and the test substance were removed 24 h following application. Remaining test substance was gently wiped from the skin, and each test site was individually examined and scored at 24 and 72 h after application for erythema and edema using the Draize skin scoring scale. For all six animals, mean scores from the 24 and 72 h readings were 3 for erythema and 1.7 for edema on intact skin. The irritant effects were not reversible within 72 h. Under the conditions of the test, the test substance was irritating to the skin.

However, the skin irritation study was considered inappropriate and not suitable for classification as the exposure conditions presenting a worst case scenario compared to the current OECD test guideline 404. According to the current OECD 404, the patch with the test substance should be loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period, which is normally 4 hours. This is in contrast to the exposure conditions of the available in-vivo skin irritation study of Cade (1980): the exposure period lasted 24 h under occlusive conditions indicating worst case conditions.

Furthermore, the available dermal acute toxicity study in rats indicates no signs of skin irritation at a dermal dose level of 2000 mg/kg bw. In accordance with column 2, 8.1.1 of Annex VIII of the REACH regulation, an in-vivo skin irritation study does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw). Based on the exposure conditions of the skin irritation study and the outcome of the acute dermal toxicity study (no signs of skin irritation), the in-vivo skin irritation study was disregarded and the result not used for classification. Based on the results of the acute dermal toxicity study, the test substance is not classified as a skin irritant.

Eye irritation was assessed and the test substance was found not to be an ocular irritant to rabbits under the conditions of the test.

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and according to Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.