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Diss Factsheets

Administrative data

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

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:
key study
Study period:
20 August 2006 to 25 August 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24th April, 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: LFC 2098
Product/common name: LFC 2098
Purpose: Industrial chemical
Colour: white
Physical state: solid, powder
Purity: 99.69%
Storage: at room temperature, protected from light
Molecular formula: C23H3104N3
Molecular weight: 413
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
New Zealand White Rabbits Hsdlf:NZW.
Source: Harlan Winkelmann GmbH, D-33l78 Borchen
3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Weights at study initiation: 2.9, 2.6 and 2.4 kg

ENVIRONMENTAL CONDITIONS
Semi-barrier in an air conditioned room
Temperature: 18 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to ssniff K-H, 4 mm V2333-000 complete diet for rabbits - maintenance, rich in crude fibre, totally pathogen free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatization period
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Test item used as provided but moistened with isotonic saline NaCl 0.9% to ensure good contact
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site
Duration of treatment / exposure:
Test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period, residual test item was removed by using tap water.
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Details on study design:
The test item was applied as a single dose to a small area (approx. 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing. Test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period, residual test item was removed by using tap water. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours.
There were no significant body weight changes during the contact and observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item LFC 2098 showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 BBC) the test item LFC 2098 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

On the basis of the test results and in conformity with the criteria given in Annex VI of the Directive, the substance should be: not classified

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 September 2006 to 14 September 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24th April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
EPA 712-C-98-195 (August 1998)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: LFC 2098
Product/common name: LFC 2098
Purpose: Industrial chemical
Colour: white
Physical state: solid, powder
Purity: 99.69%
Storage: at room temperature, protected from light
Molecular formula: C23H3104N3
Molecular weight: 413
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
New Zealand White Rabbits HsdIf:NZW. Source: Harlan Winkelmann GmbH, D-33l78 Borchen
Three female animals were used.
Body weight at the commencement of the study: 2.2, 2.2, 2.2 kg
The animals were derived from a controlled full barrier maintained breeding system (SPF)
According to Art. 92, No.7 of the German Act on Animal Welfare the animals are bred for experimental purposes.


ENVIRONMENTAL CONDITIONS
Semi-barrier in an air conditioned room
Temperature: 18 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to ssniff K-H, 4 mm V2333-000 complete diet for rabbits - maintenance, rich in crude fibre, totally pathogen free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatization period
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 0.1 g ofthe test item was applied to the test site
Duration of treatment / exposure:
The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids
were then gently held together for about 1 second in order to prevent loss of the material.
Observation period (in vivo):
Animals were observed for 72 hours after dosing
Number of animals or in vitro replicates:
3 animals
Details on study design:
The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids
were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The eyes were not rinsed.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of3 female NZW — rabbits (HsdIf:NZW) at a dose of 0.1 g per application site. The untreated other eye served as control.
Observations were calculated and compared to the control eyes, 1 h, 24 h, 48h and 72 hours post-dose. Signs of imitation were still observed at the 72 hours readings on animal No. 1; therefore, it was additionally observed 96 hours post—dose.
Animal No. 1 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1-hour post instillation. 24, 48 as well as 72 hours post instillation redness grade 1 of the conjunctivae was recorded. 96 hours post instillation no signs of irritation were recorded.
Animal No. 2 showed redness grade 1 of the conjunctivae 1, 24 as well as 48 hours post instillation. No signs of irritation were recorded 72 hours post instillation
Animal No. 3 showed redness as well as chemosis grade 1 of the conjunctivae 1 hour post instillation. 24, 48 as well as 72 hours post instillation no signs of irritation were recorded.
No other toxic effects were observed.
The eyes were not rinsed.
Throughout the observation period no weight loss was recorded in the test animals.
The calculated mean scores did not exceed the limit values according to Directive 93/21 EEC in any case.

Body weight

Animal no. Weight (kg)
Start of study End of studay
1 2.2 2.3
2 2.2 2.3
3 2.2 2.3
Interpretation of results:
GHS criteria not met
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item LFC 2098 produced slightly imitating effects, which were reversible, but no corrosion.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 BBC) the test item LFC 2098 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

On the basis of the test results given below and in conformity with the criteria given in Annex VI of the Directive, the substance should be: not classified

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test material was shown to be neither irritating to the skin nor eyes, thus is not classified under CLP.