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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was not irritating to the rabbit's skin. Following the results of two in vitro tests for the detection of eye irritating properties the substance should be regarded as a severe eye irritant.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Redderweg 8, 21147 Hamburg, Germany
- Age at study initiation: 4 - 7 months
- sex: males
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours,  and 4 to 14 days after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: slight erythema was observed in all animals 60 min after patch removal
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:




Classification: not irritating
Executive summary:

Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was tested for skin irritation properties on rabbits according to OECD TG 404. The test item was shown to be no irritant to the rabbit's skin. No systemic intolerance reactions were observed.

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion
Followed by in vitro skin corrosion and irritation tests with negative outcome (Wingenroth, 2012 a, b) carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol was tested for skin irritation properties on rabbits according to OECD TG 404 (Leuschner, 2012). The test item was shown to be no irritant to the rabbit's skin. No systemic intolerance reactions were observed.

Eye irritation/severe eye damage
No in vivo test for eye irritation was performed. Carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) in ethylene glycol showed strong irritant properties in two different not yet fully validated in vitro tests for the detection of eye irritating properties (Vohr, 2012a; Wingenroth, 2012c). According to OECD Test Guideline 405 and the 64th Competent Authority (CA) meeting November 2002, after obtaining positive results in vitro the substance can be considered a severe eye irritant (R41) and labelled accordingly. This approach is followed here and consequently, carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered as severe eye irritant.

 

Respiratory irritation

No data are available for respiratory tract irritation. Based on the predicted eye irritating potential for the substance irritating effects to the respiratory tract cannot be excluded.


Justification for selection of skin irritation / corrosion endpoint:
only one in vivo study with the substance available

Justification for selection of eye irritation endpoint:
assessment based on two in vitro studies for the detection of eye irritating properties

Effects on eye irritation: highly irritating

Justification for classification or non-classification

No classification is required with regard to skin irritation. 
Due to the results of two in vitro tests for eye irritation the substance should be regarded as severe eye irritant Category 1 according to 1272/2008 EC, corresponding to R 41 under 67/548 EEC.

No data are available for respiratory tract irritation.