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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a study already performed in the 1960s the undiluted test substance was severely irritant to the rabbit´s skin after a 20-hours contact period, as evidenced by skin inflammation with scabs and scales formation which were reversible at the end of the 14-days observation period.

In a study performed according the requirement of "Department of Transportation" (§ 173.1200, Federal Register) it was verified 1979 that the undiluted test substance was irritant but not corrosive to the rabbit´s skin after a 4-hours contact period.

Eye irritation

In a study already performed in the 1960s the undiluted test substance was irritant to the rabbit´s eye, as evidenced by reddening and swelling of the conjunctivae and diffuse areas of corneal opacity. All effects were reversible within one week after instillation of the test substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin irritation study in experimental animals was already performed in the 1960s. Therefore it is not conducted in accordance with the rules of Good Laboratory Practice (GLP) and internationally-agreed guidelines (e.g. OECD guideline No. 404), but using good scientific practices at that time.
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no information available
Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data available
Duration of treatment / exposure:
1 min., 5 min., 15 min. and 20 hour(s)
Observation period:
14 days
Number of animals:
no data available
Details on study design:
The backs and ears of very susceptible white rabbits were treated with undiluted test material. After several exposure times the application side was examined after washing (after 1, 5 and 15 minutes exposure; no washing after exposure during 20 hours). The effects observed were described qualitatively.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol concentrated and afterwards with Lutrol diluted to 50 % with water.


- Scoring system: no data, results are described qualitatively
- Examination time points: at the end of exposure

Irritation parameter:
other: qualitative description of effects
Basis:
animal:
Time point:
other: after 1, 5 and 15 minutes
Remarks on result:
no indication of irritation
Irritation parameter:
other: qualitative description of effects
Basis:
animal:
Time point:
other: 20 hours and 14 days after the end of exposure
Reversibility:
other: fully reversible within 14 days.
Remarks on result:
other: inflammation followed by degeneration involving only the upper layers of the skin
Interpretation of results:
other: irritant
Executive summary:

In a study already performed in the 1960s the undiluted test substance was severely irritant to the rabbit´s skin after a 20-hours contact period, as evidenced by skin inflammation with scabs and scales formation which were reversible at the end of the 14-days observation period.

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles
Qualifier:
according to guideline
Guideline:
other: Department of Transportation, § 173.1200, Federal Register
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Gaukler
- Mean weight at study initiation: ca. 3 kg
- Housing: individual
- Diet: Sniff K ad libitum
- Water: ad libitum
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hour(s)
Observation period:
8 days
Number of animals:
5 males, 1 female
Details on study design:
TEST SITE-Area of exposure: 2 x 2 cm, cotton cloth soaked with the test material and held in place using adhesive tape. After a 4-hours exposure the patches were removed and the test substance was removed from the application site by washing with Lutrol concentrated and Lutrol diluted to 50 %. The resulting reactions were evaluated at the end of the exposure and readings were again made 24, 48 hours and 8 days.
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal: 1-6
Time point:
other: after removal of the patch
Score:
2
Max. score:
4
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal: 1; 3-6
Time point:
other: after removal of the patch
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal #2
Time point:
other: after removal of the patch
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal: 1-6
Time point:
24/48 h
Score:
3
Max. score:
4
Remarks on result:
other: extended beyond the application area (5/6 rabbits)
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal: 1-6
Time point:
24/48 h
Score:
4
Max. score:
4
Remarks on result:
other: extended beyond the application area (3/6 rabbits at 48h)
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal #6
Time point:
other: 8d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal #6
Time point:
other: 8d
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal: 2-4
Time point:
other: 8d
Score:
2
Max. score:
4
Remarks on result:
other: with scaling extended beyond the application area
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal #5
Time point:
other: 8d
Score:
3
Max. score:
4
Remarks on result:
other: with scaling extended beyond the application area
Irritation parameter:
erythema score
Remarks:
original BASF grading
Basis:
animal #1
Time point:
other: 8d
Score:
1
Max. score:
4
Remarks on result:
other: with scaling
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal: 1; 2; 6
Time point:
other: 8d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal: 4; 5
Time point:
other: 8d
Score:
2
Max. score:
4
Irritation parameter:
edema score
Remarks:
original BASF grading
Basis:
animal #3
Time point:
other: 8d
Score:
1
Max. score:
4
Other effects:
No systemic adverse effects were observed.
Interpretation of results:
other: not corrosive
Executive summary:

In a study performed according the requirement of "Department of Transportation" (§ 173.1200, Federal Register) the undiluted test substance was not corrosive to the rabbit´s skin after a 4-hours contact period, as evidenced by erythema and oedema formation which exacerbated within 48 hours after removal of the patch and were fully reversible in only 1/6 rabbits. Also scaling but no necroses involving all layers of skin were observed at the end of  8-day observation period. Therefore the test substance should be considered an irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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: Well documented study report which meets basic scientific principles
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye irritation study in experimental animals was already performed in the 1960s. Therefore it is not conducted in accordance with the rules of Good Laboratory Practice (GLP) and internationally-agreed guidelines (e.g. OECD guideline No. 405), but using good scientific practices at that time.
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no information available.
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye treated with 0.9 % NaCl (saline) served as a control.
Duration of treatment / exposure:
30 sec exposure
Observation period (in vivo):
1 week post-instillation
Number of animals or in vitro replicates:
no information available
Details on study design:
One drop of undiluted test substance was instilled into the conjunctival sac of the rabbit eye and gently spaced it out evenly onto the ocular surface. Following 10 minutes, 1, 3 and 24 hours exposure period these eyes were evaluated. Narrative description of the degree and nature of irritation or corrosion observed.
Irritation parameter:
other: narrative description of the degree and nature of effects observed
Basis:
other: no data available
Time point:
other: 10 min, 1, 3 and 24 h
Score:
0
Remarks on result:
other: Significant irritation (redness and swelling of conjunctivae, cornea with diffuse areas of opacity)
Irritation parameter:
other: narrative description of the degree and nature of effects observed
Basis:
other: no data available
Time point:
other: over the course of one week
Score:
0
Reversibility:
fully reversible
Interpretation of results:
other: irritant
Executive summary:

In a study already performed in the 1960s the undiluted test substance was irritant to the rabbit´s eye, as evidenced by reddening and swelling of the conjunctivae and diffuse areas of corneal opacity. All effects were reversible within one week after instillation of the test substance.

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

On the basis of the available information a classification according to Regulation (EC) No 1272/2008, Annex I, is warranted:

Skin Irrit. Cat. 2  H315       

Eye Irrit. Cat. 2  H319