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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Remarks:
Tessenderlo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Guideline:
other: EPA FIFRA Guideline ( Pesticide Assessment Guidelines Subsection F 1982)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Elkhorn Rabbitry Watsonville, CA
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
4 h / exposure
Observation period:
72 h
Number of animals:
6
Details on study design:
See it in page 10th of the attachement. ( procedure part)
Irritation parameter:
erythema score
Remarks:
1
Basis:
animal #2
Time point:
other: 48h and 72 h
Score:
ca. 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Interpretation of results:
GHS criteria not met
Conclusions:
This compound produced slight temporary irrtation to the skin. Erythema score of 1were observed in 2 out of 6 rabbits at 48 and 72 hours.
Executive summary:

It is not skin irritant, based on this test, but the CLP harmonised classification found it as a Skin irritant category 2 (H315), so the recommendation is to classify it as a skin irritant Cat 2 (H335).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5)
Justification for type of information:
pH: 11.5-11.8
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
It causes serious eye irritation. It is classified as H319 ( eye irritant 2).
Executive summary:

It causes serious eye irritation. It is classified as H319 (eye irritant 2) based on CLP harmonised classification.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on CLP hamonised classification it is classifed as Skin Irrit 2 ( H315) and Eye Irrit. 2 (H319).